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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002618-15 | EudraCT Number | ||
| 67953964MDD1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the effects of aticaprant on QT/ QT interval corrected for heart rate (HR) (QTc) intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | Healthy participants will receive single oral dose of Aticaprant (Dose 1) (Treatment A) in Treatment Period 1, followed by Moxifloxacin (Dose 2) (Treatment D) in Treatment Period 2, followed by Aticaprant (Dose 3) (Treatment B) in Treatment Period 3 and then placebo (Treatment C) in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period. |
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| Treatment Sequence 2 | Experimental | Healthy participants will receive single oral dose of Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3 and then Treatment D in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period. |
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| Treatment Sequence 3 | Experimental | Healthy participants will receive single oral dose of Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment D in Treatment Period 3 and then Treatment A in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period. |
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| Treatment Sequence 4 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aticaprant Supratherapeutic Dose | Drug | Aticaprant supratherapeutic dose capsule will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in QTc at Each Time Point | Change from baseline in QTc at each time point will be reported. | Baseline up to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Aticaprant | Cmax is defined as the maximum observed plasma concentration of aticaprant and it's metabolite. | Predose up to 72 hours postdose (up to Day 4) |
| Time To Reach The Maximum Observed Concentration of Aticaprant (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| C000590915 | Aticaprant |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Experimental |
Healthy participants will receive single oral dose of Treatment D in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3 and then Treatment B in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7 to 15 days between each treatment period. |
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| Aticaprant Therapeutic Dose | Drug | Aticaprant therapeutic dose capsule will be administered orally. |
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| Placebo | Drug | Placebo will be administered orally. |
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| Moxifloxacin | Drug | Moxifloxacin capsule will be administered orally. |
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Tmax is the actual sampling time to reach the maximum observed plasma concentration of aticaprant. |
| Predose up to 72 hours postdose (up to Day 4) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to last of Aticaprant (AUC [0-last]) | AUC (0-last) is the area under the plasma concentration-time curve from time 0 to the time of the last measurable (non-below quantification limit) concentration of aticaprant. | Predose up to 72 hours postdose (up to Day 4) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time of Aticaprant (AUC[0-infinity]) | AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time of aticaprant. | Predose up to 72 hours postdose (up to Day 4) |
| Number of Participants With Adverse Events (AEs) | Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. | Up to Day 4 |
| Number of Participants with AEs of Special Interest (AESI) | Number of participants with AESIs will be reported. Pruritus and severe diarrhea is considered to be an AESI. | Up to Day 4 |
| Number of Participants With Change in Vital Signs | Number of participants with change in vital signs will be reported. Body temperature, blood pressure, and pulse/heart rate (HR) measurements will be assessed. | Up to Day 4 |
| Number of Participants With Change in Laboratory Values | Number of participants with change in laboratory parameters will be reported. Hematology, serum chemistry, and routine urinalysis will be assessed. | Up to Day 4 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |