A Phase I Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Orally Administered BPM31510 in Healthy Subjects

NCT03002935 Phase 1 COMPLETED

This is an open-label, Phase I study of the bioavailability and safety of BPM31510 administered orally in healthy subjects dosed 3 times daily for 14 days. The last study dose is administered on Day 15 (one morning dose only). The study will consist of 25 subjects.

Details

Lead sponsor	BPGbio
Phase	Phase 1
Status	COMPLETED
Enrolment	25
Start date	2017-01
Completion	2017-03

Conditions

• Healthy

Interventions

• BPM31510 Oral Nanosuspension 4%

Primary outcomes

• Maximum plasma concentration (Cmax) — Days 1, 2, 5, 15; baseline pre-dosing concentrations
  Pharmacokinetic (PK) samples collected to establish oral bioavailability.
• Area under the plasma concentration curve (AUC0-4) — Days 1, 2, 5, 15; baseline pre-dosing concentrations
  Pharmacokinetic (PK) samples collected to establish oral bioavailability.

Countries

United States