NCT04451434

Study of Danicopan in Participants of Japanese Descent

A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of Danicopan After Administration as an Oral Tablet in the Fed and Fasted States in Participants of Japanese Descent

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.

Detailed description

This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent. On Day 1 of each period, participants will receive a single oral dose of 200 milligrams (mg) danicopan under fasting conditions, 200 mg danicopan under fed conditions, or 400 mg danicopan under fed conditions. Participants will receive each treatment once, according to the randomization schedule. There will be a washout period of at least 7 days between each dose of study intervention. Safety will be assessed throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Danicopan	Oral tablet

Timeline

• Start date: 2020-08-17
• Primary completion: 2020-09-28
• Completion: 2020-09-28
• First posted: 2020-06-30
• Last updated: 2021-02-15

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study