NCT05016206

A Study of the Cardiac Effects of Danicopan in Healthy Adults

A Single Ascending Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive Controlled Study to Evaluate the Effect of ACH-0144471 on the QT Interval in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants randomized to the Treatment Arm received all 3 doses of danicopan in a single ascending fashion over 3 periods (Treatment Sequence ABC). A single oral dose of danicopan was administered with a moxifloxacin-matching placebo on Day 1 of each period. Participants randomized to the Control Arm were further randomized to receive 1 of 2 treatment sequences (Treatment Sequences EFG or IJK). A single oral dose of danicopan-matching placebo was administered with moxifloxacin or with moxifloxacin-matching placebo, as per the assigned randomization scheme, on Day 1 of each period.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-26
• Primary completion: 2018-10-12
• Completion: 2018-10-12
• First posted: 2021-08-23
• Last updated: 2021-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study