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
Trial Locations
- Locations (1)
Accel Research Sites
🇺🇸DeLand, Florida, United States