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Study of the Metabolism of Danicopan in Healthy Adults

NCT04609696 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-15

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2020-12-07
Completion
2020-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04609696 on ClinicalTrials.gov