A Phase 1 interventional study of ACP-196 and Moxifloxacin 400 mg in Healthy Volunteers, sponsored by Acerta Pharma BV. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by Acerta Pharma BV · Phase 1, Interventional, and Treatment
This study is to evaluate the effects of single therapeutic and supratherapeutic oral doses of ACP-196 on the heart rate-corrected QT interval using Fridericia's formula (QTcF).
This is a single-dose, randomized, double-blind, double-dummy, placebo- and positive-controlled, 4-period, balanced crossover study under fasting conditions. Participants will be randomized to 1 of 4 treatment sequences: ABCD, BDAC, CADB, or DCBA. On 4 different occasions (4 periods), each participant will receive Treatment A (a single therapeutic oral dose of 100 mg ACP-196), Treatment B (a single supratherapeutic oral dose of 400 mg ACP-196), Treatment C (a single oral dose of 400 mg moxifloxacin) or Treatment D (a single oral dose of ACP-196 and moxifloxacin matching placebos) according to a randomization scheme. The washout period will be >= 5 days between each dose. The clinic attempted to contact participants using their standard procedures approximately 14 days after the last study drug (or placebo) administration to determine if any adverse events (AEs) had occurred since the last dose of study drug(s). An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Acerta Pharma BV is the lead sponsor of 40 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 3 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Moxifloxacin 400 mg · Drug: Placebo
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 · Drug: Moxifloxacin 400 mg · Drug: Placebo
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 · Drug: Moxifloxacin 400 mg · Drug: Placebo
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 · Drug: Moxifloxacin 400 mg · Drug: Placebo
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.
Also known as: Acalabrutinib
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.
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.
The QTcF Change From Baseline at Postdose Timepoints (dQTcF)
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Change in Time-matched QTcF Interval Following Moxifloxicin Administration Compared With Matching Placebo
Time frame: 1, 2, 3, and 4 hour post moxifloxicin dose in each period
Change From Baseline in Heart Rate at Postdose Time Points
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Change From Baseline in PR Interval at Postdose Time Points
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Change From Baseline in RR Interval at Postdose Time Points
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Change From Baseline in QRS Interval at Postdose Time Points
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Change From Baseline in QT Interval at Postdose Time Points
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Number of Participants With Nonspecific T Waves Abnormality at Postdose Time Points
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Number of Participants With Nonspecific U Waves Abnormality at Postdose Time Points
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-last) of ACP-196
Time frame: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of ACP-196
Time frame: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Percent of AUC0-inf Extrapolated (AUC%extrap) of ACP-196
Time frame: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Maximum Measured Plasma Concentration (Cmax) of ACP-196
Time frame: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Time of the Maximum Measured Plasma Concentration (Tmax) of ACP-196
Time frame: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Apparent Terminal Elimination Rate Constant (λz) of ACP-196
Time frame: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Apparent Terminal Elimination Half-life ( t½) of ACP-196
Time frame: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Apparent Total Plasma Clearance (CL/F) of ACP-196
Time frame: -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)
Time frame: From Day 1 through 14 days after the last dose of study drug of the last period (approximately 1 month and 8 days)
Incidence of Abnormal Clinical Laboratory Parameters Reported as TEAEs
Time frame: From Day 1 through 24 hours after the last dose of study drug of the last period (approximately 1 month and 8 days)
Incidence of Abnormal Vital Signs and Physical Examinations Reported as TEAEs
Time frame: From Day 1 through 24 hours after the last dose of study drug of the last period (approximately 1 month and 8 days)
Incidence of Abnormal ECGs Reported as TEAEs
Time frame: From Day 1 through 24 hours after the last dose of study drug of the last period (approximately 1 month and 8 days)
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Acerta Pharma BV