NCT04514237

Study to Determine the Relative Bioavailability, Single and Repeat Dose Pharmacokinetics, Safety and Tolerability of BOS172767 Enantiomers in Healthy Subjects

A Phase 1 Study to Determine the Relative Bioavailability of BOS172767 Enantiomer E1 and E2 and the Single and Repeat Dose Pharmacokinetics, Safety and Tolerability of BOS172767 Selected Enantiomer in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Boston Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Part 1 of the study evaluates the safety and tolerability as well as pharmacokinetic properties of a single oral dose of BOS172767 enantiomer E1 and BOS172767 enantiomer E2 following administration to healthy participants. Part 2 of the study was to be conducted to assess the safety and tolerability as well as pharmacokinetic properties of one selected enantiomer (BOS172767-Ex) following multiple ascending doses over 14 days of dosing in healthy participants.

Detailed description

The study design of Part 1 was a double-blind, placebo-controlled, randomized, single-dose, two-way crossover, followed by two sequential ascending dose periods in 12 healthy participants. Part 2 was designed to be a double-blind, placebo-controlled, randomized multiple ascending dose (MAD) study in 36 healthy participants (12 per study cohort). Part 2 was to progress following completion of Part 1, but was not conducted.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	BOS172767 enantiomer E1 or E2	Oral tablets
DRUG	Placebo	Oral tablets

Timeline

• Start date: 2019-09-12
• Primary completion: 2020-01-22
• Completion: 2020-01-22
• First posted: 2020-08-14
• Last updated: 2020-11-18

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study