A Study of the Cardiac Effects of Danicopan in Healthy Adults

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016206
• Other study ID #: ACH471-013
• Status: Completed
• Phase: Phase 1
• Start date: July 26, 2018
• Est. completion date: October 12, 2018

Study information

• Verified date: August 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 12, 2018
• Est. primary completion date: October 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Danicopan
Danicopan tablets administered as a single oral dose.
• Moxifloxacin-matching Placebo
Moxifloxacin-matching placebo was administered as a single oral dose.
• Danicopan-matching placebo
Danicopan-matching placebo was administered as a single oral dose.
• Moxifloxacin
Moxifloxacin 400 mg was administered as a single tablet oral dose.

Locations

Country	Name	City	State
United States	Clinical Trial Site	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placebo-corrected Change From Baseline In QTc Intervals (ddQTc) For Danicopan		Pre-dose through 24 hours post-dose
Secondary	Change From Baseline In Heart Rate (HR) For Danicopan		Pre-dose through 24 hours post-dose
Secondary	Change From Baseline In QT Interval For Danicopan		Pre-dose through 24 hours post-dose
Secondary	Change From Baseline In Pulse Rate (PR) For Danicopan		Pre-dose through 24 hours post-dose
Secondary	Change From Baseline In RR Interval For Danicopan		Pre-dose through 24 hours post-dose
Secondary	Change From Baseline In QRS Interval For Danicopan		Pre-dose through 24 hours post-dose
Secondary	ddQTcF Of Moxifloxacin		Pre-dose through 24 hours post-dose
Secondary	Treatment-emergent T-wave Morphology Abnormalities And Pathologic U-waves		Pre-dose through 24 hours post-dose
Secondary	Area Under The Plasma Concentration Versus Time Curve From Time 0 To 24 Hours Post-dose (AUC0-24) Of Danicopan		Pre-dose through 24 hours post-dose
Secondary	Maximum Observed Plasma Concentration (Cmax) Of Danicopan		Pre-dose through 24 hours post-dose
Secondary	Time To Reach The Maximum Observed Plasma Concentration (Tmax) Of Danicopan		Pre-dose through 24 hours post-dose
Secondary	Number Of Participants Experiencing Treatment-emergent Adverse Events		Day 1 (postdose) through follow-up visit (14 [+/- 2] days after last study drug administration)]