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RO6953958Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (7)

Name (Synonyms) Correlation
drug1708 Other drugs Wiki 1.00
drug1592 Niclosamide Wiki 0.71
drug560 Chloroquine Wiki 0.35
drug1598 Nitazoxanide Wiki 0.35
drug923 Favipiravir Wiki 0.24
drug1270 Ivermectin Wiki 0.24
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (7)

Name (Synonyms) Correlation
D002658 Developmental Disabilities NIH 1.00
D065886 Neurodevelopmental Disorders NIH 0.71
D002659 Child Development Disorders, Pervasive NIH 0.58
D001321 Autistic Disorder NIH 0.50
D000067877 Autism Spectrum Disorder NIH 0.41
D001523 Mental Disorders NIH 0.21
D004194 Disease NIH 0.18

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0000717 Autism HPO 0.50
HP:0000729 Autistic behavior HPO 0.41

There is one clinical trial.

Clinical Trials

1 A Randomized, Investigator- /Subject-blind, Single- and Multiple-ascending Dose, Placebo-controlled Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 Following Oral Administration in Healthy Male Participants

This study will evaulate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD and MAD) and food effect (FE) of RO6953958 following oral administration in healthy male participants.

NCT04475848 Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Drug: RO6953958 Drug: Placebo
MeSH:Disease Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Autistic Disorder Neurodevelopmental Disorders Developmental Disabilities
HPO:Autism Autistic behavior

Primary Outcomes

Measure: Percentage of Participants with Adverse Events in Part 1

Time: From randomization up to 7 weeks (or up to 14 weeks if the participant is part of the food effect cohort)

Measure: Percentage of Participants with Adverse Events in Part 2

Time: From randomization up to 8 weeks

Measure: Part 2: Change in suicide risk assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)

Time: From randomization up to 8 weeks

Secondary Outcomes

Measure: Part 1: Maximum Observed Plasma Concentration (Cmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1

Measure: Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1

Measure: Part 1: Last Quantifiable Concentration (Clast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Time To the Last Quantifiable Concentration (Tlast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Terminal Elimination Phase Half-Life (T1/2) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Area Under the Concentration-Time Curve from Time 0 to 12 hours (AUC(0-12h)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Area Under the Concentration-Time Curve from Time Extrapolated to Infinity (AUC (0-inf)) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Apparent Clearance (CL/F) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Apparent Volume of Distribution (V/F) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Cumulative Amount of Unchanged Drug Excreted into the Urine (Ae) of RO6953958 and its Metabolites RO7021594 and RO7045755 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Fraction of the Administered Drug Excreted into the Urine (Fe) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Part 1: Renal Clearance of the Drug from Urine (CLR) of RO6953958 in Fasted and Fed state

Time: Day 1 to Day 5

Measure: Parts 2: Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 and Day 10

Measure: Parts 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Cmax of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 and Day 10

Measure: Parts 2: Average Plasma Concentration (Cavg) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Tmax of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 and Day 10

Measure: Part 2: Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Molecular Weight Adjusted Metabolite-to-Parent Ratio for Area Under the Concentration-Time Curve (AUC(0-t)) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: T1/2 of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: CL/F of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: V/F of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: Ae of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: Fe of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: CLR of RO6953958

Time: Day 1 to Day 14

Measure: Part 2: Trough Plasma Concentration (Ctrough) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Accumulation Ratio based on AUC (Rauc) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Accumulation Ratio Based on Cmax (RCmax) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Measure: Part 2: Accumulation Ratio based on Ctrough (RCtrough) of RO6953958 and its Metabolites RO7021594 and RO7045755

Time: Day 1 to Day 14

Related HPO nodes (Using clinical trials)

HP:0000717: Autism
Genes 196
NLGN4X DNM1 SHANK3 PIK3CA DHCR7 LIMK1 SOX3 GJA5 PTCHD1 TSC2 SCN3A STS KCNAB2 SLC13A5 SCN8A ACTL6B NLGN4X ELN CNKSR2 SLC1A2 PWAR1 LHX1 PIGL ATP6V1A NLGN3 ATRX ADSL MED13L NIPBL PRDM16 TSC1 DPYD SCN8A FTSJ1 TBX1 DYM SYNJ1 TBCK DYRK1A WWOX CHRNA7 TRAK1 AUTS2 RREB1 SEMA3E TSC2 NTRK2 HNF1B NPAP1 CHD7 NAGA TCF12 SMC3 CACNA1C GABRA2 RERE YY1 PRKAR1A NRXN1 CACNA1B CHD8 WFS1 RAD21 MECP2 ARVCF FLCN NDN STS SKI SDHC TBR1 BAZ1B PROKR2 CYFIP2 UBE3A NDP SOX2 IL1RAPL1 HERC2 AP3B2 EEF1A2 MAGEL2 GP1BB KCNB1 REV3L SMC1A NONO GTF2IRD1 UFD1 STXBP1 SNORD115-1 NUS1 MED12 CACNA1A MKRN3-AS1 GAMT SH2B1 RFC2 GABRG2 KLLN GRIN2D PLXND1 SLC9A6 GTF2I IFNG MEIS2 EXT2 EP300 CLTC ALDH5A1 ANKRD11 DHCR7 SIN3A SNRPN FGFR1 CLIP2 GRIA3 COMT NECAP1 NAGA HESX1 ZBTB20 FMR1 SZT2 OPHN1 NHS JMJD1C EHMT1 AARS1 FMR1 UBA5 TMLHE ARV1 NLGN3 MED13L DMPK HIRA YWHAG CREBBP MKRN3 SEC23B TBX1 PARS2 SIM1 SETD5 EHMT1 AKT1 ARNT2 KCNA2 ALMS1 SNORD116-1 PPP3CA GABRB2 PDE4D CNTNAP2 TSC1 KDM5C TBL2 OTX2 SDHB GJA8 SNRPN TBX1 GABRD DEAF1 PWRN1 KMT2A USF3 PTEN SATB2 FGF12 RPL10 IQSEC2 DHDDS PDE4D AHDC1 BCKDK SLC35C1 HDAC4 SEC24C GABRA5 PAH MAOA IPW SMAD4 MAN1B1 RAI1 KCNA2 HCN1 NFIB PTEN GATM SYNGAP1 HDAC8 ALG13 SDHD
Protein Mutations 1
S1009A
SNP 1
rs6971
HP:0000729: Autistic behavior
Genes 557
SNX14 PPM1D NLGN4X PIGY CAMTA1 TMEM231 SLC6A8 LIMK1 SOX3 CHD2 GJA5 CLCN4 MICOS13 LMAN2L TSC2 STS KCNAB2 SLC13A5 ARID1B SCN8A ND2 NLGN4X TCF4 NUS1 CLP1 ELN CNKSR2 SCN1A DEPDC5 SLC1A2 PWAR1 NLGN3 GABRG2 ATRX ADSL MED13L UCHL1 CHD2 TMEM138 GNAQ ADGRV1 RAB39B TSC1 DPYD ALDH18A1 SCN8A ARHGEF6 TBX1 SYNJ1 CDKL5 DYRK1A WWOX CHRNA7 TRAK1 SH2B1 NDUFS3 NDUFV2 IREB2 WDR26 EP300 ARX SPECC1L IL1RAPL1 DLG4 SHANK3 CACNA1C GABRA2 NDUFB11 EGF SLC25A22 ZC3H14 CLIP1 MTOR USP7 PIGQ GATAD2B BCOR CTCF MECP2 CUX2 TIMMDC1 MAPT NDUFAF8 NDUFB10 CACNA1B ANK3 C12ORF4 AFF2 NTNG2 RAD21 MCTP2 DDX3X NALCN ARVCF FBXO31 FLCN VPS13C RPS6KA3 MBOAT7 MED25 MID2 GABRG2 RERE KDM6B NDN TBR1 STS CUX2 NDUFS6 FOXRED1 MBOAT7 TRAPPC9 SKI SDHC HNRNPH2 TBR1 MED13 TAF1 NDUFAF4 WFS1 MED23 EXT2 TSPAN7 TBX2 IL1RAPL1 JAM2 TMEM216 SRP54 NEXMIF SCN1B ASXL3 EEF1A2 MAGEL2 KCNB1 SMC1A GTF2IRD1 UFD1 STAG1 NDUFS8 NDUFAF3 SNORD115-1 PIGV TMEM126B MED12 TBC1D23 CACNA1A GAMT SH2B1 RARS1 RFC2 DMXL2 GABRG2 SLC9A6 NTRK2 PPP2R5D GRN CC2D2A MEIS2 NDUFAF3 FOXP1 EP300 CLTC IQSEC2 ALG13 FRMPD4 ANKRD11 EXTL3 SIN3A SNRPN CACNA2D2 FGFR1 CLIP2 GRIA3 COMT NECAP1 HESX1 HCN1 SZT2 OPHN1 PIGP NHS JMJD1C TCF20 GRIA3 AARS1 FRRS1L UBA5 NDUFS2 TMLHE NDUFV1 PRSS12 PCGF2 NLGN3 KDM5B MED13L DMPK AUTS2 HIRA CDKL5 AP3B2 IQSEC2 CARS2 SYT1 YWHAG PGAP1 SRY STAG2 NAA10 CREBBP OTUD6B CHD2 TRRAP GNAO1 MAN1B1 RAB11B TM4SF20 PRODH UGP2 SEC23B RSRC1 ASH1L PARS2 ZNF41 ST3GAL3 IQSEC1 CXORF56 RERE EHMT1 AKT1 PCDH19 CNNM2 KCNA2 GABRD ZNF711 ALMS1 SYNGAP1 DEAF1 NDUFAF2 SYP SCN9A POMT1 GJA8 GDI1 KCNA1 SETD5 SLC9A7 PCDH19 CDKL5 TBX1 HECW2 TUSC3 NDUFB3 POLA1 PWRN1 USP7 KMT2A AIMP1 AP1S2 PTEN SATB2 ST3GAL3 FGF12 RPL10 IQSEC2 DHDDS GPHN CLCN4 PDE4D AHDC1 EDC3 BCKDK SCN2A SLC35C1 HDAC4 CRBN SEC24C TCF4 NEUROD2 PAH HIVEP2 MECP2 IPW ARFGEF2 KCNA2 HCN1 SLC25A12 GATM NR2F1 SCN2A SON SYNGAP1 MED12 HDAC8 PGAP2 NDUFS7 SCN1B MEIS2 SDHD C9ORF72 DNM1 RSPRY1 SHANK3 PIK3CA DHCR7 NDUFAF5 PTCHD1 TMEM237 SCN3A STXBP1 CHD1 CRADD SIM1 ACTL6B FTSJ1 MAPK8IP3 CDH15 ALG11 KMT5B POLA1 UPF3B LINS1 SMG9 ND3 HERC1 GRIN1 LHX1 PIGL ATP6V1A SETD2 SYNJ1 NIPBL TUBB3 HCFC1 KCNT1 PRDM16 VAMP2 MEF2C NEUROD2 ATP1A3 FTSJ1 DYM SNCA TBCK MEF2C SCN9A CXORF56 AUTS2 INTS1 RREB1 SLC45A1 SEMA3E ADNP TSC2 NTRK2 HNF1B PODXL NPAP1 CHD7 SNX14 SCN2A NAGA RSPRY1 BCORL1 TCF12 SMC3 SLC25A1 ACOX1 AGTPBP1 NDUFS1 PIGP GABRA1 CASK CTNNB1 LRRK2 RERE YY1 PRKAR1A DCPS NRXN1 TAF1 CHD8 PSMD12 WFS1 ACADL PIGC MECP2 CNKSR2 AP2M1 SARS1 NAA10 PARK7 CC2D1A HTRA2 BAZ1B PROKR2 KMT2C ND1 CYFIP2 NDUFS4 UBE3A TREM2 NDP TRIM8 SOX2 MECP2 C12ORF4 FOXP2 HERC2 TLK2 AP3B2 GP1BB ARX REV3L UBTF NONO EZR STXBP1 VCP ZNF423 NDUFAF4 NUS1 ADNP MKRN3-AS1 MSTO1 PTCHD1 ACSL4 NSUN2 TNIK PINK1 TET3 SLC6A8 KLLN GRIN2D DNM1 PLXND1 CLCN4 CDK8 ZIC1 GRIK2 GTF2I IFNG EXT2 SLC6A1 USP27X FMN2 ALDH5A1 DHCR7 THOC2 PDE4D RORA POGZ NAGA COG5 ZBTB20 FMR1 NDUFA6 SH2B1 EHMT1 PIGO FMR1 RPS23 HCN1 ARV1 ALG13 AGTR2 PIGL PACS2 PUF60 SLC35A3 NDUFS4 FOXG1 HERC2 PAK3 SQSTM1 TWNK CEP290 STXBP1 MKRN3 NDUFA1 TBX1 TBC1D24 NDUFA11 SYN1 CNTNAP2 PRKN SIM1 SETD5 OTUD6B NEXMIF FRMPD4 PACS1 DPYD ARNT2 PNKP B3GALNT2 NDST1 SNORD116-1 DOCK7 NDUFAF1 PPP3CA DLG3 GFM1 GABRB2 PPP2CA PDE4D CNTNAP2 HNMT TSC1 TRIO KDM5C SIK1 METTL23 WASHC4 STX1B TBL2 OTX2 RNF135 SDHB CTCF ZFPM2 PIGW DMD TMEM106B SNRPN SLC35A3 GABRD DEAF1 PSEN1 GABRB3 USF3 SCN1A NDUFB9 NDUFA13 GABRA5 CHMP2B MAOA NAA15 TECR SCN1A SMAD4 MAN1B1 MAPK10 UBA5 USP9X RAI1 NFIB PTEN KPTN PGAP3 PIGG SCN1B SPATA5 ALG13 PUF60 ZNF81 DNAJC6 NUBPL
Protein Mutations 1
S1009A
SNP 1
rs6971