A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers
Phase 1
Completed
- Conditions
- Drug-drug Interactions
- Interventions
- Drug: cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate
- Registration Number
- NCT03411122
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-sequence 3-period napabucasin Period 1: napabucasin 240 mg BID on days 1-2 Period 2: cytochrome P450 probe drugs during days 1-4 Period 3: napabucasin 240 mg BID on days 1-11, cytochrome P450 probe drugs during days 6-9 Single-sequence 3-period cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate Period 1: napabucasin 240 mg BID on days 1-2 Period 2: cytochrome P450 probe drugs during days 1-4 Period 3: napabucasin 240 mg BID on days 1-11, cytochrome P450 probe drugs during days 6-9
- Primary Outcome Measures
Name Time Method Pharmacokinetics for probe drugs by assessing plasma concentration Predose and up to 7 days post dose Pharmacokinetics for napabucasin by assessing plasma concentration Predose and up to 7 days post dose
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of napabucasin in modulating CYP450 enzymes and BCRP transporters?
How does napabucasin compare to other CYP450 inhibitors in terms of drug interaction potential and safety?
What biomarkers are associated with napabucasin's pharmacokinetic effects in healthy volunteers?
What adverse events were observed in NCT03411122 and how were they managed in the study design?
Are there any combination therapies involving napabucasin that show promise in mitigating drug interactions?
Trial Locations
- Locations (1)
Accel Research Sites
🇺🇸DeLand, Florida, United States
Accel Research Sites🇺🇸DeLand, Florida, United States