Covid 19 Research using Clinical Trials (Home Page)
The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:Wiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated MeSH Terms (20)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001997 | Bronchopulmonary Dysplasia NIH | 1.00 |
| D008595 | Menorrhagia NIH | 1.00 |
| D006929 | Hyperaldosteronism NIH | 1.00 |
| D014552 | Urinary Tract Infections NIH | 1.00 |
| D054559 | Hyperphosphatemia NIH | 1.00 |
| D004314 | Down Syndrome NIH | 1.00 |
| D000309 | Adrenal Insufficiency NIH | 1.00 |
| D007008 | Hypokalemia NIH | 1.00 |
| D009080 | Mucocutaneous Lymph Node Syndrome NIH | 0.71 |
| D006470 | Hemorrhage NIH | 0.71 |
| D001289 | Attention Deficit Disorder with Hyperactivity NIH | 0.50 |
| D020141 | Hemostatic Disorders NIH | 0.30 |
| D001778 | Blood Coagulation Disorders NIH | 0.30 |
| D006973 | Hypertension NIH | 0.28 |
| D004194 | Disease NIH | 0.18 |
| D013577 | Syndrome NIH | 0.11 |
| D003141 | Communicable Diseases NIH | 0.09 |
| D007239 | Infection NIH | 0.06 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
| D018352 | Coronavirus Infections NIH | 0.04 |
Correlated HPO Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002905 | Hyperphosphatemia HPO | 1.00 |
| HP:0002900 | Hypokalemia HPO | 1.00 |
| HP:0000846 | Adrenal insufficiency HPO | 1.00 |
| HP:0000132 | Menorrhagia HPO | 1.00 |
| HP:0000859 | Hyperaldosteronism HPO | 1.00 |
| HP:0007018 | Attention deficit hyperactivity disorder HPO | 0.50 |
| HP:0001928 | Abnormality of coagulation HPO | 0.30 |
| HP:0000822 | Hypertension HPO | 0.28 |
There is one clinical trial.
Clinical Trials
1 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
NCT04278404 Coronavirus Infection (COVID-19) Pulmonary Arterial Hypertension Urinary Tract Infections in Children Hypertension Pain Hyperphosphatemia Primary Hyperaldosteronism Edema Hypokalemia Heart Failure Hemophilia Menorrhagia In Insomnia Pneumonia Skin Infection Arrythmia Asthma in Children Bronchopulmonary Dysplasia Adrenal Insufficiency Fibrinolysis; Hemorrhage Attention Deficit Hyperactivity Disorder Multisystem Inflammatory Syndrome in Children (MIS-C) Kawasaki Disease Coagulation Disorder Down Syndrome Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Down Syndrome Menorrhagia Hypertension Hemostatic Disorders Mucocutaneous Lymph Node Syndrome Blood Coagulation Disorders Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Disease Syndrome Hemorrhage Attention Deficit Disorder with Hyperactivity
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Adrenal insufficiency Attention deficit hyperactivity disorder Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism
Primary Outcomes
Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Elimination rate constant (ke) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Half-life (t1/2) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Absorption rate constant (ka) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: AUC (area under the curve) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Maximum concentration (Cmax) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Related HPO nodes (Using clinical trials)
HP:0001928: Abnormality of coagulation
Genes 218
STIM1 SPTB PGM1 F7 EPB42 NOP10 MPI SERPINC1 NGLY1 STAT5B PEX16 RBM8A PTH1R A2ML1 RRAS2 OSTM1 DPM2 ANO6 GPR35 WRAP53 PML GP1BA F2 COG8 GNA14 F10 RFT1 HADH TERT PEX1 ALG2 PEX5 PROC ORAI1 F7 ALDOB PLG VKORC1 SRD5A3 PEX6 PEX26 AKR1D1 TCF4 F5 PROS1 GP9 BCOR RFT1 ITGA2B THBD ALG12 CFI IRF2BP2 PEX19 HRG F8 LMAN1 HSD3B7 MYD88 LMAN1 ZBTB16 MRAS PEX10 F2 HMGCL HAVCR2 STX11 AGA F9 SERAC1 AGGF1 LARS1 KLKB1 NUMA1 ABCC2 RARA F11 NRAS MST1 PEX12 SSR4 NBAS F13A1 ATP6V0A2 RTEL1 CYP7B1 F11 TEK CBL FIP1L1 NR1H4 SSR4 F8 UNC13D SRD5A3 TINF2 F13A1 HSD3B7 NPM1 SLC25A13 ANK1 CYP7B1 PMM2 ITGB3 EFL1 SOS2 PIGA VPS33A PEX14 PRF1 ATP6V1A GPC1 GNE PEX11B FAH GGCX HBB B4GALT1 MCFD2 PRKAR1A IDH1 MAP2K1 RTEL1 RASA2 XIAP LMNA NABP1 FLNA SLC30A10 VWF NPM1 SLC25A15 GFI1B UQCRFS1 NBEAL2 F8 DKC1 STAT3 PLAT CFH TFAM ATP6V0A2 GP1BA CACNA1S FGG KRAS GGCX DOLK TBL1XR1 FGA BRAF VWF F12 GATA2 ACD SOS1 TERC MPDU1 RYR1 PROS1 DPM1 PTPN11 LZTR1 PTPN11 TERT GGCX HMGCL DDOST F10 F9 MGAT2 AHCY FGB PARN IDH2 GATA6 BCS1L SLC4A1 RYR1 RAF1 GP1BB SPTA1 DLD F8 SERPINF2 PEX13 HELLPAR ALG6 COG4 GP1BB ATP6V1E1 RIT1 GP9 SERPINC1 ACAD9 NHP2 SLC7A7 PEX3 DPAGT1 PARN PROC TRMU CD46 RRAS F13B LYST USB1 ZMPSTE24 CTC1 PEX2 PMM2 AMACR DKC1 MCFD2 F13B F5 TINF2 HAVCR2 Protein Mutations 0
SNP 0
HP:0003256: Abnormality of the coagulation cascade
Genes 139
PRF1 ATP6V1A GPC1 GNE SPTB PGM1 F7 GGCX EPB42 MPI SERPINC1 NGLY1 STAT5B MCFD2 PRKAR1A MAP2K1 OSTM1 XIAP DPM2 ANO6 LMNA NABP1 FLNA SLC30A10 VWF GPR35 PML GP1BA SLC25A15 GFI1B F2 COG8 GNA14 F10 NBEAL2 RFT1 F8 HADH STAT3 CFH TFAM ATP6V0A2 PROC F7 GP1BA ALDOB CACNA1S PLG FGG VKORC1 SRD5A3 TBL1XR1 FGA AKR1D1 BRAF VWF TCF4 F5 PROS1 GP9 BCOR F12 ITGA2B MPDU1 RYR1 CFI IRF2BP2 PROS1 DPM1 F8 PTPN11 LMAN1 HSD3B7 LMAN1 HMGCL ZBTB16 DDOST F10 F9 MGAT2 F2 AHCY HMGCL FGB BCS1L HAVCR2 SLC4A1 RYR1 GP1BB STX11 SPTA1 AGA F9 F8 SERAC1 HELLPAR LARS1 NUMA1 RARA F11 MST1 SSR4 ALG6 COG4 GP1BB ATP6V1E1 NBAS F13A1 GP9 SERPINC1 ATP6V0A2 ACAD9 SLC7A7 CYP7B1 F11 DPAGT1 PROC TRMU FIP1L1 NR1H4 CD46 F13B F8 ZMPSTE24 UNC13D SRD5A3 F13A1 NPM1 SLC25A13 ANK1 PMM2 PMM2 AMACR ITGB3 EFL1 MCFD2 F13B F5 HAVCR2 Protein Mutations 0
SNP 0
HP:0000846: Adrenal insufficiency
Genes 133
MKRN3-AS1 CYP11B2 STAR PEX14 PROP1 BAP1 PEX19 PEX11B TERT SMO PEX14 SGPL1 HBB PEX16 STEAP3 MAP3K1 MC2R BAP1 TBX19 ZFPM2 CTNNB1 PEX5 SNRPN WWOX PWAR1 SAMD9 VAMP7 PEX6 AIRE GLI3 AIRE CYP11B2 HSD3B2 SAA1 TBCK PEX1 SCNN1B PIK3CA DHX37 BRAF PEX5 PEX5 AAAS PEX13 NNT RBM28 CYP11B1 PEX10 PEX11B SMARCB1 PEX6 PEX26 LHX4 SOX9 NPAP1 MC2R MKRN3 AKT1 NR0B1 ABCD1 CYP17A1 CYP11A1 WT1 RBM28 HBB PCSK1 MEN1 POMC PCSK1 NR3C2 PEX19 PEX1 MRAP MRAP MCM4 POR SNORD116-1 PEX12 NR5A1 PEX10 GLI3 CYP11A1 KCNJ11 SRY NR3C1 TBX19 TCTN3 BCOR ABCC8 CYP11B2 PEX13 PEX3 LIPA NFKB2 NR0B1 DMRT3 NFKB2 PWRN1 NDN PEX12 CYP11A1 POMC HSD11B2 CDH23 AIP PEX2 AAAS TXNRD2 PDGFB GMPPA PEX26 PEX3 CDH23 SMARCE1 GK IARS2 IPW TXNRD2 TRAF7 GATA4 CYP11B1 HERC2 SUFU HSD17B4 MAGEL2 PEX2 MRPS7 HSD11B2 PEX16 TRAPPC11 NF2 SNORD115-1 PEX6 Protein Mutations 1
N363S SNP 0
HP:0007018: Attention deficit hyperactivity disorder
Genes 272
PPM1D DRD4 DNM1 DHCR7 SLC6A8 LIMK1 PTCHD1 CLCN4 TSC2 SCN3A STS DHTKD1 STAG2 SLC13A5 PMS2 SIM1 ACTL6B LHCGR FTSJ1 EPCAM HOXA2 KIF11 ELN CNKSR2 UPF3B GABRG2 UPF3B DRD5 SLC1A2 PWAR1 CLTC SETBP1 ATP6V1A NIPBL GNAQ GNE RAI1 RAB39B HCFC1 TSC1 SCN8A FGFR3 SCN8A ARHGEF6 TBX1 DYM HSPG2 SYNJ1 MED12 CACNA1H WWOX CHRNA7 MLH3 GNB5 TRAK1 CXORF56 MSH2 GALC RREB1 SEMA3E CPLX1 ADNP TSC2 NTRK2 NPAP1 CHD7 ARX CRBN ABCD1 BCORL1 SPRED1 TMCO1 IL1RAPL1 DYNC1I2 SMC3 GABRA2 RAI1 SH3KBP1 FGD1 NKAP PIEZO2 YY1 FLI1 RSRC1 GABRG2 MLXIPL CACNA1B TGFBR2 CNKSR2 C12ORF4 SMPD1 YWHAG RAD21 MCTP2 IGF1 CNKSR2 ARVCF RPS6KA3 MID2 RERE NDN IKBKG MAPK1 STS GLUD1 IQSEC2 SEMA4A ASPM HDC BAZ1B MED13 TAF1 WAC CYFIP2 UBE3A TBC1D24 NDP TSPAN7 SIN3A ALKBH8 MECP2 OCRL HERC2 ZDHHC9 TLK2 DPP6 AP3B2 EEF1A2 MAGEL2 GP1BB KCNB1 SMC1A GTF2IRD1 PIK3CA UFD1 RIC1 STXBP1 FAN1 SNORD115-1 NUS1 CACNA1A MKRN3-AS1 PTCHD1 ACSL4 SH2B1 GRIN2A TET3 RFC2 GNE GABRG2 PCNT GRIN2D LIG4 PANK2 CDK8 GTF2I PRKCG IFNG BMPR1A FOXP1 USP27X CLTC KIF14 DEAF1 SRPX2 SPG7 SIN3A SNRPN CLIP2 CRKL COMT NECAP1 GABRA1 GRIN2A SZT2 OPHN1 SH2B1 JMJD1C AARS1 FMR1 UBA5 SOX5 VPS13A NOP56 ARV1 PCGF2 ALG13 AGTR2 AUTS2 HIRA BCR IQSEC2 YWHAG PAK3 GRIA4 TBX1 NSUN2 MSH6 PMS1 MKRN3 JRK TBX1 GABRB3 PARS2 ZNF41 RERE MLH1 DPH1 FLII SETD5 CIC FRMPD4 KRAS KCNA2 TKT ZNF711 TRIO SNORD116-1 ELN PPP3CA MED12 DLG3 FGD1 GABRB2 GATA4 SYP TSC1 TRIO TBL2 CSNK2A1 GDI1 DMD SETD5 SLC9A7 PHIP TBX1 POLA1 PWRN1 MED12 RPS20 USP7 KMT2A TUBB2B MAP11 SATB2 FGF12 DNAJC12 DHDDS HDAC4 TIMM8A SEC24C GABRA5 PAH PRNP THRB IPW TKT ARF1 USP9X RAI1 KCNA2 NBN HCN1 SLC2A1 NR2F1 SYNGAP1 MED12 HDAC8 SLITRK1 ARID2 ZNF81 PAH HP:0000859: Hyperaldosteronism
Genes 29
SCNN1B SLC26A3 CLCNKB KCNJ5 KCNJ1 INSR CYP11B2 KCNJ10 SCNN1G KCNJ5 CYP11B1 SCNN1A NR3C2 CLCNKB CACNA1D OCRL SCNN1A TP53 CYP11B1 CLCNKB SLC12A1 CYP11B1 CLCNKA CYP17A1 BSND CYP11A1 SLC12A3 SCNN1G SCNN1B Protein Mutations 1
H295R SNP 0
HP:0002905: Hyperphosphatemia
Genes 27
GNAS TBCE GNA11 PGAP2 GNAS PRKAR1A GALNT3 GCM2 GNAS STX16 PDE4D PTH CACNA1S GNAS RYR1 ZMPSTE24 TNFRSF11B GNAS-AS1 TBCE FAM111A LMNA GNAS GNAS FAM111A STX16 RYR1 CASR Protein Mutations 0
SNP 0
HP:0000822: Hypertension
Genes 411
PLIN1 SMARCAL1 LIMK1 SDCCAG8 ELP1 TSC2 FMR1 CPOX GNAS COX1 SH2B3 LYZ CLCN2 NF1 NOTCH3 ARL6 EDA2R ELN APOA1 CTLA4 CC2D2A MLX FGFR2 ADA2 TRNC MMP14 MTRR BANF1 GLA TRNK TRNL1 CCR6 GPC3 CYP11B2 ERCC8 TRIM32 CFH ACVRL1 COL3A1 LRP6 TRNK XYLT2 CFI CALR ITGA8 SLC37A4 SUGCT GBA NF1 CD46 WT1 WRN KLHL3 BBS4 THPO SDHA POU6F2 ABCG8 CORIN NFIX PDE8B NOD2 ARVCF INVS PRKAR1A RET GLA SLC25A11 SCNN1A TRIM28 TRNQ OFD1 B2M WT1 TNFRSF11B ARMC5 FGFR2 HLA-DPB1 PPARG EDA TP53 BNC2 ALX4 LMX1B NPHP1 ACAT1 ACTA2 GNAS GTF2IRD1 SDHC UFD1 ENPP1 GATA5 LEMD3 MYH11 HGD SDHD RET RFC2 IRF5 KCNJ5 LDLR ERCC6 DLST REST CAV1 GANAB BBS10 SMAD3 TET2 TRNW MUC1 POU3F4 OFD1 ADA2 SDHB ERCC4 BBS9 CD2AP LMNA CYP11B1 MEF2A MMP2 CLIP2 COL4A3 ELN COMT HPSE2 BBS2 XYLT1 PRKACA JMJD1C SMAD4 VANGL1 G6PC WNK4 DIS3L2 TMEM70 HBB ENPP1 MAFB LZTFL1 TRNS2 PKD2 USP8 HIRA TRIP13 DNAJB11 FBN1 TGFBR1 CFHR1 SH2B3 PKD1 LMNA PRKAR1A SDHB SCN2B PRTN3 NR3C2 WDR35 MDH2 DNMT3A ELP1 ALMS1 ELN TRNL1 IQCB1 RET MKKS YY1AP1 LARS2 AIP TBX1 TGFBR2 SPRY2 FBN1 NOTCH1 ABCB6 PRKACA MTTP MYLK ARL6 ABCC6 TRAF3IP1 COL5A2 RET STOX1 H19 LEMD3 FGA TMEM67 SEC24C MAX CYP11B1 SLC25A11 ND6 KIF1B ACTN4 ADA2 HSD11B2 DYRK1B NPHP1 BMPR2 PDE3A ND1 TTC8 JAK2 MGP NOTCH2 VHL SDHB SDHAF2 VHL MYMK NPHP3 ABCC6 TGFBR3 PPARG ALMS1 SMAD6 TRPC6 CCDC28B TMEM127 VHL TNFRSF11A SCNN1B BBS5 SCNN1B ARHGAP31 APOB SDHD SDHD PDE3A GDNF RREB1 CYP11B1 ECE1 TMEM237 TRNE SDHC FH YY1AP1 LMNA TGFB2 COX3 GPR101 CYP17A1 BRCA2 THBD LMX1B WNK1 LRIG2 FIG4 CEP290 HLA-DRB1 XPNPEP3 CCND1 MKS1 ACTA2 FUZ COL4A3 CYTB SMAD4 LMNA TRNV SLC2A10 FBN1 PRKG1 COQ7 MLXIPL KIF1B AIP FLT1 SERPINA6 CFB PLIN1 HLA-B NKX2-5 WT1 PKD1 EGFR MC4R EPAS1 SLC2A10 GCH1 BAZ1B NSMCE2 VHL PCSK9 KRT8 WT1 WDPCP TRNK PKD2 APRT HLA-DPA1 MPL COL4A5 KCTD1 SDHD TRIM28 GP1BB THSD1 BBS12 CEP290 FMO3 CYP21A2 CUL3 NPHP4 PKHD1 BICC1 COL4A4 BSCL2 NR3C1 WT1 GANAB C3 COX2 TRNF IFT27 GTF2I STAT1 SDCCAG8 PAM16 MFAP5 LOX IL12B SLC37A4 LDLRAP1 MYH7 BBS7 TGFB3 CBS ARMC5 CEP164 ADAMTSL4 INVS CDH23 COL5A1 CACNA1D LMNA PTPN22 SCNN1A SDHB ABCG5 TBX1 FN1 TMEM127 BBS1 CYP17A1 FN1 RPGRIP1L AIP PHF21A CACNA1H POR ND5 ENG BBS1 PDE11A EXT2 COL1A1 GUCY1A1 TSC1 FBN1 TBL2 HMBS HMBS C8ORF37 NR3C1 FOXF1 PRKAR1A NPHP1 CEP19 KRT18 MAX ABCC6 VAC14 KIF1B KCTD1 TRNS1 HSD11B2 GJA1 SCNN1G KCNJ5 BBIP1 PDE11A ANGPTL6 CDH23 KCNJ5 MAT2A SMAD4 IDUA IFT172 CACNA1D WDR19 ZMPSTE24 CYP11B1 FOXE3 CCN2 GNAS SCNN1G GUCY1A1 NFU1 VHL USP8 CFHR3 NOS3 COL3A1 JAK2 OSGEP HP:0002900: Hypokalemia
Genes 81
KCNE2 SCN4A GATM SLC12A3 CLCNKB SCN10A KCNJ1 INSR CAV3 SCN4A KCNE3 BMPR1A INSR CLCN2 CACNA1S KCNJ5 NR3C1 KCNJ2 CTNS AIP CLCNKB SCN4B SLC12A1 SCN4A CLCNKA AKAP9 CASR SCN4A SLC4A1 SNTA1 HSD11B2 CACNA1S SLC2A2 CACNA1C SCNN1B SLC26A3 KCNH2 FXYD2 SCNN1G KCNJ5 KCNJ18 SCNN1A SCNN1B CACNA1S CDH23 USP8 CYP11B2 KCNJ10 KCNJ5 KCNQ1 CYP11B1 KCNJ18 CDH23 CLCNKB CYP11B1 CACNA1D OCRL CACNA1D TP53 KCNE1 CYP11B1 CALM2 SCNN1A ATP1A1 ANK2 NOS1AP TRDN SMAD4 CALM1 HSD11B2 CACNA1S CYP17A1 SCN5A BSND SCNN1G SLC12A3 USP8 CLDN10 MAGED2 COL3A1 GABRA3 Protein Mutations 0
SNP 0
Primary Outcomes
Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Elimination rate constant (ke) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Half-life (t1/2) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Absorption rate constant (ka) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: AUC (area under the curve) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Maximum concentration (Cmax) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.