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CYP and transporter probe substrates

Phase 1

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Jul 13, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Clinical trial landscape

CYP and transporter probe substrates · 1 trial · 1 indication

Phase 1 1
NCT02578277Study on Effects of BMS-955176 on the Pharmacokinetics of Probe SubstratesHIV Infections
COMPLETED59 Analytics
PHASE1COMPLETED
Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax (maximum observed concentration)
Days 1 to 18
AUC(0-T), area under the concentration-time curve from time zero to the time of the last quantifiable concentration
Days 1 to 18
AUC(INF), area under the concentration-time curve from time zero extrapolated to infinite time
Days 1 to 18
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Single sequence, 3-period DDI (drug-drug interaction)EXPERIMENTALSingle sequence

Interventions

NameTypeDescription
CYP and transporter probe substratesDRUGCocktail of CYP (cytochrome P450) and transporter probe substrates
BMS-955176DRUGBMS-955176
BMS-955176 plus CYP and transporter probe substratesDRUGBMS-955176 plus the cocktail of CYP and transporter probe substrates
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Written Informed Consent 2. Healthy male and female (not of childbearing potential) subjects as determined by medical history, surgical history, physical examination, vital signs, ECGs, and clinical laboratory determinations 3. Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m...

Countries:United States
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Frequently asked questions about CYP and transporter probe substrates

What is CYP and transporter probe substrates used for in HIV Infections?

CYP and transporter probe substrates are investigational small molecules being studied for use in HIV Infections. They are currently in Phase 1 clinical development, with one completed trial involving 59 participants. The drug is not approved and remains under investigation for this indication.

What does CYP and transporter probe substrates target?

CYP and transporter probe substrates are designed to interact with cytochrome P450 (CYP) enzymes and drug transporters. These targets are involved in drug metabolism and disposition, and the drug is being studied to understand its effects on the pharmacokinetics of other medications in the context of HIV treatment.

Who makes CYP and transporter probe substrates?

CYP and transporter probe substrates is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research on this investigational drug for the treatment of HIV Infections.

What phase is CYP and transporter probe substrates in?

CYP and transporter probe substrates is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is still in the early stages of clinical testing, with one Phase 1 trial completed to date.

What clinical trials is CYP and transporter probe substrates in?

CYP and transporter probe substrates has one completed clinical trial, NCT02578277, titled 'Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates'. This Phase 1 study enrolled 59 participants with HIV Infections in the United States and included healthy volunteers.