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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003776-39 | EudraCT Number | ||
| R018553NAP1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the effects of loperamide on QT/ QT interval corrected for heart rate (QTc) intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: Treatment ADBC | Experimental | Participants will receive treatment A (Loperamide therapeutic dose) on Day 1 on treatment period 1, followed by Treatment D (Moxifloxacin) on Day 1 of treatment period 2 followed by Treatment B (Loperamide supratherapeutic dose) on Day 1 of treatment period 3 followed by Treatment C (placebo) on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day. |
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| Treatment Sequence 2: Treatment BACD | Experimental | Participants will receive Treatment B on Day 1 of treatment period 1 followed by Treatment A on Day 1 of treatment period 2 then Treatment C on Day 1 of treatment period 3 and then Treatment D on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day. |
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| Treatment Sequence 3: Treatment CBDA | Experimental | Participants will receive Treatment C on Day 1 of treatment period 1 followed by Treatment B on Day 1 of treatment period 2 then Treatment D on Day 1 of treatment period 3 and then Treatment A on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day. |
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| Treatment Sequence 1: Treatment DCAB | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loperamide | Drug | Loperamide will be administered as a single oral dose at the expected therapeutic or supratherapeutic doses respectively. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in QT Interval Corrected for Heart Rate (QTc) Intervals for Loperamide | Change from baseline in QTc intervals for loperamide at therapeutic and supratherapeutic doses will be reported. | Baseline up to 9 weeks |
| Percentage of Participants with Change from Baseline in T-wave Morphology | The percentage of participants in each treatment having T-wave morphology changes from baseline that represent the appearance or worsening of the morphological abnormality will be reported. | Up to 9 weeks |
| Percentage of Participants with Occurrence of Abnormal U-wave Morphology | The percentage of participants with the occurrence of abnormal U-waves morphology that represent the appearance or worsening of the morphological abnormality will be reported. | Up to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Loperamide and its M1 Metabolite | Cmax is defined as the maximum observed plasma concentration. | Up to 9 weeks |
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Loperamide and its M1 Metabolite |
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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 |
|---|---|
| D008139 | Loperamide |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
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Participants will receive Treatment D on Day 1 of treatment period 1 followed by Treatment C on Day 1 of treatment period 2 then Treatment A on Day 1 of treatment period 3 and then Treatment B on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day.
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| Placebo | Other | Matching loperamide placebo capsules will be administered orally. |
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| Moxifloxacin | Drug | Moxifloxacin tablets will be administered orally. |
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Tmax is defined as the time to reach the maximum observed plasma concentration. |
| Up to 9 weeks |
| Area Under the Plasma Concentration-Time Curve from the Time of Dosing to the Last Measurable Plasma Concentration AUC (0-last) of Loperamide and its M1 Metabolite | AUC (0-last) is defined as the area under the plasma concentration-time curve from the time of dosing to the last measurable plasma concentration. | Up to 9 weeks |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC[0-inifinity]) of Loperamide and M1 Metabolite | (AUC[0-inifinity]) is defined as the area under the plasma concentration-time curve from time zero to infinity, calculated as AUClast+Clast/lambda (z), where Clast is the last observed measurable concentration. | Up to 9 weeks |
| Apparent Terminal Elimination Rate Constant Lambda (z) of Loperamide and its M1 Metabolite | Lambda (z) is defined as the apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log-transformed concentration versus time curve. | Up to 9 weeks |
| Apparent Elimination Half-Life Associated with the Terminal Slope (t1/2) of Loperamide and M1 Metabolite | t1/2 is defined as the apparent elimination half-life associated with the terminal slope lambda (z) of the semilogarithmic drug concentration-time curve. | Up to 9 weeks |
| Metabolite to parent ratio (M/P) for (AUC[0-inifinity]) of Loperamide and M1 Metabolite | M/p ratio is defined as metabolite to parent ratio (M/P) for (AUC[0-inifinity]) corrected for molecular weight using the following molecular weights: loperamide 477.045 gram per mol (g/mol), M1 463.018 g/mol. | Up to 9 weeks |
| Relationship Between Systemic Plasma Concentrations of Loperamide and QT/QTc Changes | The relationship between systemic plasma concentrations of loperamide and change in QT/QTc will be reported. | Up to 9 weeks |
| Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 9 Weeks |
| D042462 |
| 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |