A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-DOSE ESCALATION, MULTIPLE-DOSE ESCALATION, AND FOOD EFFECT STUDY OF FLX475 IN HEALTHY MALE AND FEMALE SUBJECTS
Completed
- Conditions
- Cancer Treatment10027656
- Registration Number
- NL-OMON44307
- Lead Sponsor
- FLX Bio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 104
Inclusion Criteria
- healthy male or female subjects
- 18-55 yrs, inclusive
- BMI: 18.0-30.0 kg/m2, inclusive
- non-smoking
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A: To evaluate the safety and tolerability of single oral ascending doses<br /><br>of FLX475 administered to healthy male and female subjects<br /><br><br /><br>Part B: To evaluate safety and tolerability of multiple oral ascending doses of<br /><br>FLX475 administered for 14 days to healthy male and female subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part A:<br /><br>- To evaluate the pharmacokinetics (PK) of FLX475 following administration of<br /><br>single oral ascending doses of FLX475 administered to healthy male and female<br /><br>subjects<br /><br>- To assess the food effect (FE) on the PK of FLX475 following administration<br /><br>of a single oral dose of FLX475 administered to healthy male and female<br /><br>subjects<br /><br>- To compare the PK of an alternative drug product formulation of FLX475<br /><br>following administration of a single oral dose administered to healthy male and<br /><br>female subjects<br /><br><br /><br>Part B:<br /><br>- To evaluate the PK of FLX475 following administration of multiple oral<br /><br>ascending doses of FLX475 administered to healthy male and female subjects</p><br>