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A Drug Interaction Study of Danicopan

NCT04709094 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-01-14

No results posted yet for this study

Summary

This was a 3-part study (Part 1, Part 2, Part 3) with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.

Conditions

  • Healthy

Interventions

DRUG

Danicopan

Danicopan was dosed as 2 x 100 milligram (mg) tablets.

DRUG

Warfarin

Warfarin was dosed as 2 x 10 mg and 1 x 5 mg warfarin sodium tablets (Coumadin or generic equivalent).

DRUG

Bupropion

Bupropion was dosed as Wellbutrin (or generic equivalent) as 1 x 100 mg tablet.

DRUG

Ethinyl Estradiol/Norethindrone

EE/NET (0.035 mg/1 mg) was dosed as Ortho-Novum-1/35 (or generic equivalent) fixed-dose combination tablets.

Sponsors & Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

    collaborator INDUSTRY

  • Celerion

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-28
Primary Completion
2019-10-14
Completion
2020-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04709094 on ClinicalTrials.gov