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rosuvastatinWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug2810 enzalutamide Placebo Wiki 1.00
drug2804 digoxin Wiki 1.00
drug2809 enzalutamide Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D011471 Prostatic Neoplasms NIH 0.58

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0012125 Prostate cancer HPO 0.58

There is one clinical trial.

Clinical Trials

1 A Phase 1 Open-label Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates of P-glycoprotein (Digoxin) and Breast Cancer Resistant Protein (Rosuvastatin) in Male Subjects With Prostate Cancer

The primary purpose of this study is to determine the effect of multiple once daily administrations of enzalutamide on the pharmacokinetics of a single dose of digoxin (P-glycoprotein (P-gp) substrate) and rosuvastatin (breast cancer resistant protein (BCRP) substrate) in participants with prostate cancer. This study will also evaluate the safety and tolerability of multiple once daily administrations of enzalutamide alone and in combination with a single dose of digoxin (P-gp substrate) and rosuvastatin (BCRP substrate) in participants with prostate cancer, as well, assess the pharmacokinetics of enzalutamide and its active metabolite.

NCT04094519 Prostate Cancer Drug: enzalutamide Drug: enzalutamide Placebo Drug: digoxin Drug: rosuvastatin
MeSH:Prostatic Neoplasms
HPO:Prostate cancer Prostate neoplasm

Primary Outcomes

Description: Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.

Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: maximum concentration (Cmax)

Time: Up to Day 71

Description: AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected.

Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)

Time: Up to Day 71

Description: AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.

Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf)

Time: Up to Day 71

Secondary Outcomes

Description: Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered an Investigational Product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. An AE is considered "serious" if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures)or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.

Measure: Number of participants with Adverse Events (AEs)

Time: Up to Day 101

Description: Number of participants with potentially clinically significant laboratory values.

Measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs)

Time: Up to Day 101

Description: Number of participants with potentially clinically significant vital sign values.

Measure: Number of participants with vital sign abnormalities and /or adverse events (AEs)

Time: Up to Day 101

Description: Number of participants with potentially clinically significant ECG values.

Measure: Number of participants with routine 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)

Time: Up to Day 101

Description: Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.

Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: maximum concentration (Cmax)

Time: Up to Day 71

Description: AUCtau will be recorded from the pharmacokinetic (PK) plasma samples collected.

Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: area under the concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval (AUCtau)

Time: Up to Day 71

Description: Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected.

Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)

Time: Up to Day 71

Related HPO nodes (Using clinical trials)

HP:0012125: Prostate cancer
Genes 32
TP53 RNF43 PTEN CDH1 CHEK2 ZFHX3 EPHB2 STAT6 BRIP1 BMPR1A NAB2 GREM1 APC RAD50 TP53 RAD51D RAD51C KLF6 MXI1 BARD1 CHEK2 MAD1L1 BRCA1 AR NBN BRCA2 RNASEL PTEN BRCA2 MRE11 RAD51 PALB2
Protein Mutations 8
D104N E17K F876L G80A G84E P13K S9346A T878A
SNP 1
rs2987983
HP:0100787: Prostate neoplasm
Genes 32
TP53 RNF43 PTEN CDH1 CHEK2 ZFHX3 EPHB2 STAT6 BRIP1 BMPR1A NAB2 GREM1 APC RAD50 TP53 RAD51D RAD51C KLF6 MXI1 BARD1 CHEK2 MAD1L1 BRCA1 AR NBN BRCA2 RNASEL PTEN BRCA2 MRE11 RAD51 PALB2
Protein Mutations 0
SNP 0