A Study of the Cardiac Effects of Danicopan in Healthy Adults

NCT05016206 | Completed Phase 1 FDA Drug

• 1 other identifier: ACH471-013
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Danicopan; ALXN2040; ACH-0144471; Electrocardiogram; QT Interval; Concentration-QT

Outcome Measures

Primary Outcomes (1)

• Placebo-corrected Change From Baseline In QTc Intervals (ddQTc) For Danicopan

  Pre-dose through 24 hours post-dose

Secondary Outcomes (11)

• Change From Baseline In Heart Rate (HR) For Danicopan

  Pre-dose through 24 hours post-dose

• Change From Baseline In QT Interval For Danicopan

  Pre-dose through 24 hours post-dose

• Change From Baseline In Pulse Rate (PR) For Danicopan

  Pre-dose through 24 hours post-dose

• Change From Baseline In RR Interval For Danicopan

  Pre-dose through 24 hours post-dose

• Change From Baseline In QRS Interval For Danicopan

  Pre-dose through 24 hours post-dose

Study Arms (2)

Treatment Arm (ABC)

EXPERIMENTAL

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.

Drug: Danicopan; Drug: Moxifloxacin-matching Placebo

Control Arm (EFG and IJK)

PLACEBO COMPARATOR

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.

Drug: Moxifloxacin-matching Placebo; Drug: Danicopan-matching placebo; Drug: Moxifloxacin

Interventions

Danicopan DRUG

Danicopan tablets administered as a single oral dose.

Also known as: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Treatment Arm (ABC)

Moxifloxacin-matching Placebo DRUG

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

Control Arm (EFG and IJK); Treatment Arm (ABC)

Danicopan-matching placebo DRUG

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

Control Arm (EFG and IJK)

Moxifloxacin DRUG

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

Also known as: Avelox

Control Arm (EFG and IJK)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• Achillion, a wholly owned subsidiary of Alexion: collaborator

Study Sites (1)

Clinical Trial Site

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

danicopan; rhoA GTP-Binding Protein; Moxifloxacin

Intervention Hierarchy (Ancestors)

rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Intracellular Signaling Peptides and Proteins; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a double-dummy, placebo- and positive-controlled study.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 23, 2021
• Study Start: July 26, 2018
• Primary Completion: October 12, 2018
• Study Completion: October 12, 2018
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)