NCT04609696

Study of the Metabolism of Danicopan in Healthy Adults

A 2-Part, Open-Label, Randomized, Single-Dose, 3-Period Crossover, Phase 1, Relative Bioavailability, and Food Effect Study, Comparing Different Formulations of Danicopan in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.

Detailed description

For both parts of this study, on Day 1 of each period, participants will receive a single oral dose of danicopan as either the prototype powder-in-capsule (PIC) formulation (1 or 2) under fed conditions, the prototype PIC formulation (1 or 2) under fasting conditions, or the tablet formulation under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Danicopan: Powder-In-Capsule 1	Danicopan (200 milligrams) will be administered orally on Day 1.
DRUG	Danicopan: Powder-In-Capsule 2	Danicopan (200 milligrams) will be administered orally on Day 1.
DRUG	Danicopan: Tablet	Danicopan (200 milligrams) will be administered orally on Day 1.

Timeline

• Start date: 2020-10-20
• Primary completion: 2020-12-07
• Completion: 2020-12-07
• First posted: 2020-10-30
• Last updated: 2022-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study