NCT03198624

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects

A Two-part, Single and Multiple Dose, Parallel Group Study to Assess Safety and Pharmacokinetics of Oral HTL0018318 in Healthy Japanese and Caucasian Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Nxera Pharma UK Limited · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.

Detailed description

This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects. The study will be conducted in two parts: (A) single doses of HTL0018318 in healthy, adult, male Caucasian and Japanese subjects; (B) multiple doses of HTL0018318 in healthy, adult, male Caucasian and Japanese subjects.

Conditions

• Safety Issues
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	HTL0018318	Part A single dose Part B five doses
DRUG	Placebo oral capsule	Part B only

Timeline

• Start date: 2017-05-16
• Primary completion: 2017-08-20
• Completion: 2017-08-20
• First posted: 2017-06-26
• Last updated: 2017-09-07

Locations

1 site across 1 country: United Kingdom