A Study to Evaluate the Effect of ACP-196 on the Heart Rate-corrected QT Interval in Healthy Adult Participants

Study identifier:ACE-HV-005

ClinicalTrials.gov identifier:NCT04867980

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Randomized, Double-Blind, Double-Dummy, Placebo- and Positive Controlled, 4-Way Crossover Study to Assess the Effect of Single-Dose ACP-196 on the QTc Interval in Healthy Adult Subjects

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

ACP-196, Moxifloxacin 400 mg, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Apr 2016

Primary Completion Date: 09 May 2016

Study Completion Date: 09 May 2016

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2021 by Acerta Pharma BV

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Continuous non-smoker participant who has not used nicotine-containing products for >= 3 months before the first dose
- Have body mass index of >= 18.0 and <= 32.0 kg/m^2 at screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the principal investigator (PI)
- No clinically significant history or presence of ECG findings as judged by the PI or qualified designee at screening and each check-in, including each criterion as: 1) Normal sinus rhythm (heart rate between 50 and 100 beats per minute [bpm]), 2) QTcF interval ≤ 450 milliseconds (msec), 3) QRS interval ≤ 110 msec, and 4) PR interval ≤ 220 msec
- Women participants must be of non-childbearing status
- Women participants must have negative serum pregnancy test
- ability to swallow multiple capsules and/or tablets using size 0 blank capsules (up to a maximum of 5 capsules per participant)
- Male participants must be willing to use protocol specified contraception methods

Exclusion Criteria

- Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- Presence of any clinically significant, ongoing systemic bacterial, fungal, or viral infections (including upper respiratory tract infections, but excluding localized cutaneous fungal infections), in the opinion of the PI
- History of any major surgical procedure within 30 days before the first dose of study drug
- History or presence of alcoholism or drug abuse within the past 2 years before screening
- Any clinically significant condition that may affect ACP-196 absorption in the opinion of the PI, including gastric restrictions and bariatric surgery (eg, gastric bypass).
- Allergy to band-aids, adhesive dressing, or medical tape
- History or presence of clinically significant thyroid disease
- Prior exposure to Bruton's tyrosine kinase inhibitors (eg, ACP-196, ibrutinib) within 3 months before the first dose of study drug
- Positive urine cotinine at screening
- Positive urine drug or alcohol results at screening or each check-in
- Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at screening
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening
- Seated heart rate is lower than 50 bpm or higher than 99 bpm at screening
- Unable to refrain from or anticipates the use of protocol defined medications for 28 days before the first dose of study drug and throughout the study

Location

Celerion

Tempe, Arizona, United States, 85283

Arms	Assigned Interventions
Experimental: ABCD Participant will receive a single oral dose of 4 study treatments with the sequences of ABCD. The washout period will be >= 5 days between each dose.	Drug: ACP-196 Participants will receive a single oral dose of 100 mg ACP-196 (1 x 100 mg capsule) on Day 1 (Treatment A) and 400 mg ACP-196 (4 x 100 mg capsules) on Day 1 (Treatment B) according to the randomization scheme. Other Name: Acalabrutinib Drug: Moxifloxacin 400 mg Participants will receive a single oral dose of 400 mg moxifloxacin (1 x 400 mg tablet) on Day 1 (Treatment C) according to the randomization scheme. Drug: Placebo Participants will receive a single oral dose of ACP-196 matching placebo (4 x 100 mg matching placebo capsules) and moxifloxacin matching placebo (1 x 400 mg matching placebo tablet) on Day 1 (Treatment D) according to the randomization scheme.
Experimental: BDAC Participant will receive a single oral dose of 4 study treatments with the sequences of BDAC. The washout period will be >= 5 days between each dose.	Drug: ACP-196 Participants will receive a single oral dose of 100 mg ACP-196 (1 x 100 mg capsule) on Day 1 (Treatment A) and 400 mg ACP-196 (4 x 100 mg capsules) on Day 1 (Treatment B) according to the randomization scheme. Other Name: Acalabrutinib Drug: Moxifloxacin 400 mg Participants will receive a single oral dose of 400 mg moxifloxacin (1 x 400 mg tablet) on Day 1 (Treatment C) according to the randomization scheme. Drug: Placebo Participants will receive a single oral dose of ACP-196 matching placebo (4 x 100 mg matching placebo capsules) and moxifloxacin matching placebo (1 x 400 mg matching placebo tablet) on Day 1 (Treatment D) according to the randomization scheme.
Experimental: CADB Participant will receive a single oral dose of 4 study treatments with the sequences of CADB. The washout period will be >= 5 days between each dose.	Drug: ACP-196 Participants will receive a single oral dose of 100 mg ACP-196 (1 x 100 mg capsule) on Day 1 (Treatment A) and 400 mg ACP-196 (4 x 100 mg capsules) on Day 1 (Treatment B) according to the randomization scheme. Other Name: Acalabrutinib Drug: Moxifloxacin 400 mg Participants will receive a single oral dose of 400 mg moxifloxacin (1 x 400 mg tablet) on Day 1 (Treatment C) according to the randomization scheme. Drug: Placebo Participants will receive a single oral dose of ACP-196 matching placebo (4 x 100 mg matching placebo capsules) and moxifloxacin matching placebo (1 x 400 mg matching placebo tablet) on Day 1 (Treatment D) according to the randomization scheme.
Experimental: DCBA Participant will receive a single oral dose of 4 study treatments with the sequences of DCBA. The washout period will be >= 5 days between each dose.	Drug: ACP-196 Participants will receive a single oral dose of 100 mg ACP-196 (1 x 100 mg capsule) on Day 1 (Treatment A) and 400 mg ACP-196 (4 x 100 mg capsules) on Day 1 (Treatment B) according to the randomization scheme. Other Name: Acalabrutinib Drug: Moxifloxacin 400 mg Participants will receive a single oral dose of 400 mg moxifloxacin (1 x 400 mg tablet) on Day 1 (Treatment C) according to the randomization scheme. Drug: Placebo Participants will receive a single oral dose of ACP-196 matching placebo (4 x 100 mg matching placebo capsules) and moxifloxacin matching placebo (1 x 400 mg matching placebo tablet) on Day 1 (Treatment D) according to the randomization scheme.

Documents available

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Download
Trial Results Summaries
Available here

Contacts

Contact

Priti Patel

Investigators

Principal Investigator

Priti Patel

Acerta Clinical Trials

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Celerion

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=ACE-HV-005&amp;attachmentIdentifier=8f659fa2-c64c-44ad-95d9-87418ece674f&amp;fileName=ACE-HV-005-_Study_Synopsis_-_CSR-redacted.pdf&amp;versionIdentifier=

Trial Results Summaries

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-HV-005&attachmentIdentifier=8f659fa2-c64c-44ad-95d9-87418ece674f&fileName=ACE-HV-005-_Study_Synopsis_-_CSR-redacted.pdf&versionIdentifier=