Healthy VolunteersPhase 1NCT04867980
A Study to Evaluate the Effect of ACP-196 on the Heart Rate-corrected QT Interval in Healthy Adult Participants
A Phase 1 study testing ACP-196 and Moxifloxacin 400 mg in people with Healthy Volunteers, run by Acerta Pharma BV at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ACP-196 and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 9 May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- ACP-196, Moxifloxacin 400 mg, Placebo
- Keywords
- ACE-HV-005, ACP-196, Healthy participants, Volunteers, Adults, QTc Interval, Pharmacokinetics, PK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-196Drug
Also called Acalabrutinib
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.
Moxifloxacin 400 mgDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ABCD | Experimental | 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. Receives: Drug: ACP-196; Drug: Moxifloxacin 400 mg; Drug: Placebo |
| BDAC | Experimental | 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. Receives: Drug: ACP-196; Drug: Moxifloxacin 400 mg; Drug: Placebo |
| CADB | Experimental | 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. Receives: Drug: ACP-196; Drug: Moxifloxacin 400 mg; Drug: Placebo |
| DCBA | Experimental | 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. Receives: Drug: ACP-196; Drug: Moxifloxacin 400 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The QTcF Change From Baseline at Postdose Timepoints (dQTcF)
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in each period
Secondary outcomes (20)
Change in Time-matched QTcF Interval Following Moxifloxicin Administration Compared With Matching Placebo
Measured: 1, 2, 3, and 4 hour post moxifloxicin dose in each period
Change From Baseline in Heart Rate at Postdose Time Points
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: -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
Measured: -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
Measured: -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
Measured: -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
Measured: -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
Measured: -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
Measured: -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
Measured: -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)
Measured: 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
Measured: 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
Measured: 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
Measured: From Day 1 through 24 hours after the last dose of study drug of the last period (approximately 1 month and 8 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Apr 2016
- Primary completion9 May 2016
- Study completion9 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Acerta Pharma BVThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Priti Patel, MD, Study director, Acerta Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867980
- Sponsor's protocol ID
- ACE-HV-005
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04867980
- Acronym / sponsor ID
- ACE-HV-005
- Conditions
- Healthy Volunteers
- Keywords
- ACE-HV-005, ACP-196, Healthy participants, Volunteers, Adults, QTc Interval, Pharmacokinetics, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Acerta Pharma BVIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 9 May 2016 (actual)
- Study completion
- 9 May 2016 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABCD | Experimental | Drug: ACP-196, Drug: Moxifloxacin 400 mg, Drug: PlaceboParticipant 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. |
| BDAC | Experimental | Drug: ACP-196, Drug: Moxifloxacin 400 mg, Drug: PlaceboParticipant 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. |
| CADB | Experimental | Drug: ACP-196, Drug: Moxifloxacin 400 mg, Drug: PlaceboParticipant 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. |
| DCBA | Experimental | Drug: ACP-196, Drug: Moxifloxacin 400 mg, Drug: PlaceboParticipant 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP-196Also: AcalabrutinibParticipants 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. | Drug | ABCD, BDAC, CADB, DCBA |
| Moxifloxacin 400 mgParticipants 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 | ABCD, BDAC, CADB, DCBA |
| PlaceboParticipants 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. | Drug | ABCD, BDAC, CADB, DCBA |
Primary outcome
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
20 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: 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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Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priti Patel, MD study director
Acerta Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACP-196 and Moxifloxacin 400 mg in people with Healthy Volunteers, run by Acerta Pharma BV at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.