Phase 1Completed
A Safety Study of Orally Administered BPM31510 in Healthy Subjects
A Phase I Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Orally Administered BPM 31510 in Healthy Subjects
- Sponsor
- BPGbio (Industry)
- Enrolment
- 20 enrolled
- Conditions
- Healthy
- Interventions
- BPM31510 Oral Nanosuspension 4%
- Ages
- adults, older adults
- Registry
- NCT02486055
From the registry
This is an open-label, Phase I study of the bioavailability and safety of BPM31510 in healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a single administration. Cohort 1 and Cohort 2 will consist of 10 patients each. The cohorts may be enrolled sequentially.
Primary outcomes
- Cmax