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A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants

NCT03384186 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-08-20

No results posted yet for this study

Summary

The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.

Conditions

  • Healthy

Interventions

DRUG

Danicopan Modified Release Prototype 1

Danicopan (400 milligrams \[mg\]) oral tablet.

DRUG

Danicopan Modified Release Prototype 2

Danicopan (400 mg) oral tablet.

DRUG

Danicopan Modified Release Prototype 3

Danicopan (800 mg) oral tablet.

Sponsors & Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-03-21
Completion
2018-03-21
FDA Drug
Yes

Countries

  • United Kingdom

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 NCT03384186 on ClinicalTrials.gov