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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004302-25 | EudraCT Number | ||
| TMC207NTM1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the effect of steady-state clarithromycin once every 12 hour on the pharmacokinetic parameters of bedaquiline and its active metabolite M2 after a single dose of bedaquiline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: Bedaquiline and Clarithromycin | Experimental | Participants will receive bedaquiline on Day 1 in Period 1, followed by clarithromycin on Days 1-14 and bedaquiline on Day 5 in Period 2. There will be washout period of at least 28 days starting on Day 1. |
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| Treatment Sequence 2: Clarithromycin and Bedaquiline | Experimental | Participants will receive clarithromycin on Days 1-14 and bedaquiline on Day 5 in Period 1, followed by bedaquiline on Day 1 in Period 2. There will be a washout period of at least 28 days starting after bedaquiline administration on Day 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bedaquiline | Drug | Bedaquiline tablet will be administered, orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Analyte Concentration (Cmax) of Bedaquiline and its Metabolite (M2) | Cmax is the maximum observed analyte concentration. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, and 240 hours Post-dose |
| Minimum Observed Analyte Concentration (Cmin) of Bedaquiline and its Metabolite (M2) | Cmin is the minimum observed analyte concentration. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, and 240 hours Post-dose |
| Area Under the Analyte Concentration versus Time Curve (AUC) From Time of Administration up to 72 Hours Post Dosing (AUC72h) of Bedaquiline and its Metabolite (M2) | AUC72h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 72 hours post dosing, calculated by linear-linear trapezoidal summation. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hours Post-dose |
| Area Under the Analyte Concentration versus Time Curve (AUC) From Time of Administration up to 240 Hours Post Dosing (AUC240h) of Bedaquiline and its Metabolite (M2) | AUC240h is the area under the analyte concentration-time curve from time 0 to 240 hours, calculated by linear-linear trapezoidal summation. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, and 240 hours Post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Clarithromycin and its Metabolite 14-OH-Clarithromycin | Cmax is the maximum observed analyte concentration. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, and 12 hours Post-dose |
| Time to Reach Maximum Observed Analyte Concentration (Tmax) of Clarithromycin and its Metabolite 14-OH-Clarithromycin |
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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 |
|---|---|---|---|---|---|---|
| SGS Life Science Services | Antwerp | 2060 | 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 |
|---|---|
| C493870 | bedaquiline |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Clarithromycin | Drug | Clarithromycin tablet will be administered, orally. |
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Tmax is the actual sampling time to reach the maximum observed analyte concentration. |
| Pre-dose, 1, 2, 3, 4, 5, 6, 8, and 12 hours Post-dose |
| Cmin of Clarithromycin and its Metabolite 14-OH-Clarithromycin | Cmin is the minimum observed analyte concentration. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, and 12 hours Post-dose |
| Area Under the Analyte Concentration versus Time Curve (AUC) From Time of Administration up to 12 Hours Post Dosing (AUC12h) of Clarithromycin and its Metabolite 14-OH-Clarithromycin | AUC12h is the area under the analyte concentration versus time curve (AUC) from time of administration up to 12 hours post dosing, calculated by linear-linear trapezoidal summation. | Pre-dose, 1, 2, 3, 4, 5, 6, 8, and 12 hours Post-dose |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | An adverse event 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 90 days |
| Organic Chemicals |