MedTrace Logo

A Study of the Cardiac Effects of Danicopan in Healthy Adults

NCT05016206 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-08-23

No results posted yet for this study

Summary

This was a randomized, double-blind, double-dummy, placebo- and positive-controlled, 2-arm (Treatment Arm and Control Arm), parallel study to evaluate the effect of ACH-0144471 (danicopan) on the QT interval in healthy adult participants.

Conditions

  • Healthy

Interventions

DRUG

Danicopan

Danicopan tablets administered as a single oral dose.

DRUG

Moxifloxacin-matching Placebo

Moxifloxacin-matching placebo was administered as a single oral dose.

DRUG

Danicopan-matching placebo

Danicopan-matching placebo was administered as a single oral dose.

DRUG

Moxifloxacin

Moxifloxacin 400 mg was administered as a single tablet oral dose.

Sponsors & Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2018-10-12
Completion
2018-10-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05016206 on ClinicalTrials.gov