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Completed

NCT Number: NCT05016206

A Study of the Cardiac Effects of Danicopan in Healthy Adults

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Tempe, Arizona, 85283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key 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.

Key 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.

Treatment and study plan

Danicopan

Drug

Danicopan tablets administered as a single oral dose.

Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Moxifloxacin-matching placebo

Drug

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

Danicopan-matching placebo

Drug

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

moxifloxacin

Drug

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

Other names: Avelox

Primary outcomes

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

    Time frame: Pre-dose through 24 hours post-dose

Secondary outcomes

  1. Change From Baseline In Heart Rate (HR) For Danicopan

    Time frame: Pre-dose through 24 hours post-dose

  2. Change From Baseline In QT Interval For Danicopan

    Time frame: Pre-dose through 24 hours post-dose

  3. Change From Baseline In Pulse Rate (PR) For Danicopan

    Time frame: Pre-dose through 24 hours post-dose

  4. Change From Baseline In RR Interval For Danicopan

    Time frame: Pre-dose through 24 hours post-dose

  5. Change From Baseline In QRS Interval For Danicopan

    Time frame: Pre-dose through 24 hours post-dose

  6. ddQTcF Of Moxifloxacin

    Time frame: Pre-dose through 24 hours post-dose

  7. Treatment-emergent T-wave Morphology Abnormalities And Pathologic U-waves

    Time frame: Pre-dose through 24 hours post-dose

  8. Area Under The Plasma Concentration Versus Time Curve From Time 0 To 24 Hours Post-dose (AUC0-24) Of Danicopan

    Time frame: Pre-dose through 24 hours post-dose

  9. Maximum Observed Plasma Concentration (Cmax) Of Danicopan

    Time frame: Pre-dose through 24 hours post-dose

  10. Time To Reach The Maximum Observed Plasma Concentration (Tmax) Of Danicopan

    Time frame: Pre-dose through 24 hours post-dose

  11. Number Of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: Day 1 (postdose) through follow-up visit (14 [+/- 2] days after last study drug administration)]

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2021
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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