A Study of the Cardiac Effects of Danicopan in Healthy Adults

NCT ID: NCT05016206

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2018-10-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Treatment Arm (ABC)

Treatment Sequence ABC - Participants received all 3 doses of danicopan in ascending fashion over 3 periods:

Treatment A (Period 1): Danicopan 400 milligrams (mg) and moxifloxacin-matching placebo.

Treatment B (Period 2): Danicopan 800 mg and moxifloxacin-matching placebo.

Treatment C (Period 3): Danicopan 1200 mg and moxifloxacin-matching placebo.

Group Type: EXPERIMENTAL

Danicopan

Intervention Type: DRUG

Danicopan tablets administered as a single oral dose.

Moxifloxacin-matching Placebo

Intervention Type: DRUG

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

Control Arm (EFG and IJK)

Participants received 1 of 2 treatment sequences (Treatment Sequence EFG or Treatment Sequence IJK) over 3 periods:

Treatment E (Period 1): Danicopan-matching placebo (400 mg) and moxifloxacin-matching placebo.

Treatment F (Period 2): Danicopan-matching placebo (800 mg) and moxifloxacin 400 mg.

Treatment G (Period 3): Danicopan-matching placebo (1200 mg) and moxifloxacin-matching placebo.

Treatment I (Period 1): Danicopan-matching placebo (400 mg) and moxifloxacin 400 mg.

Treatment J (Period 2): Danicopan-matching placebo (800 mg) and moxifloxacin-matching placebo.

Treatment K (Period 3): Danicopan-matching placebo (1200 mg) and moxifloxacin 400 mg.

Group Type: PLACEBO_COMPARATOR

Moxifloxacin-matching Placebo

Intervention Type: DRUG

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

Danicopan-matching placebo

Intervention Type: DRUG

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

Moxifloxacin

Intervention Type: DRUG

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

Interventions

Danicopan

Danicopan tablets administered as a single oral dose.

Intervention Type: DRUG

Moxifloxacin-matching Placebo

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

Intervention Type: DRUG

Danicopan-matching placebo

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

Intervention Type: DRUG

Moxifloxacin

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

Intervention Type: DRUG

Other Intervention Names

ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471; Avelox

Eligibility Criteria

Inclusion Criteria

• Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50 kg at screening.
• Female participants must have been of nonchildbearing potential.
• Nonsterile male participants must have agreed to abstinence or used a highly effective method of contraception.
• No clinically significant history or presence of electrocardiogram findings at screening and check-in.

Exclusion Criteria

• Evidence of any clinically significant deviation from normal in clinical laboratory evaluations.
• History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
• History or presence of drug or alcohol abuse within 2 years prior to first dosing; current tobacco/nicotine user or a positive cotinine test at screening; positive for alcohol and/or drugs-of-abuse screen at screening or first check-in.
• Any previous procedure that could alter absorption or excretion of orally administered drugs.
• A history of significant multiple and/or severe allergies or had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
• Body temperature ≥ 38°Celsius on Day -2 or Day 1 prior to first dosing; history of febrile illness, or other evidence of infection, within 14 days prior to first dosing.
• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever was longer.
• Donation of whole blood from 3 months before first dosing, or of plasma from 30 days before first dosing; received blood products within 6 months before first dosing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Achillion, a wholly owned subsidiary of Alexion

INDUSTRY

Sponsor Role: collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Tempe, Arizona, United States

Countries

United States

Other Identifiers

ACH471-013

Identifier Type: -

Identifier Source: org_study_id