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| ID | Type | Description | Link |
|---|---|---|---|
| TMC207-TiDP13-C112 | Other Identifier | Tibotec-Virco Virology BVBA | |
| 2009-016437-99 | EudraCT Number |
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The purpose of this study is to assess the pharmacokinetics (what the body does to the medication), safety and tolerability of TMC207 and its N-monodesmethyl metabolite (M2) in healthy participants and in patients with moderate hepatic impairment after administration of a single 400 mg dose of TMC207.
This is a Phase I, open label (all people know the identity of the intervention) study of TMC207. The study consists of a screening period and a 4-weeks treatment period. Sixteen participants will be enrolled in two panels. Panel A will include 8 patients of moderate hepatic impairment and Panel B will include 8 healthy participants. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. The entire study duration for each participant will be approximately 7 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A | Experimental | 8 patients with moderate hepatic impairment classified as moderate as per the Child Pugh Classification. |
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| Panel B | Experimental | 8 healthy participants who will match to patients with hepatic impairment in Panel A with regards to sex, age (more or less to 5 years), and body mass index. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC207 | Drug | 400 mg (4 tablets of 100 mg) of TMC207 will be administered as a single dose on Day 1 of the treatment period to participants of both the Panels (Panel A and Panel B) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration of TMC207 | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours | |
| Time to reach the maximum plasma concentration of TMC207 | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours | |
| Area under curve from time of administration up to 72 hours post dosing of TMC207 | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours | |
| Area under curve from time of administration up to the last time point with a measurable concentration post dosing of TMC207 | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours | |
| Area under curve extrapolated to infinity of TMC207 | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours | |
| Maximum plasma concentration of N-monodesmethyl metabolite | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours | |
| Time to reach the maximum plasma concentration of N-monodesmethyl metabolite | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours | |
| Area under curve from time of administration up to 72 hours post dosing of N-monodesmethyl metabolite | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours | |
| Area under curve from time of administration up to the last time point with a measurable concentration post dosing of N-monodesmethyl metabolite |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events as a measure of safety and tolerability | up to Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tibotec-Virco Virology BVBA Clinical Trial | Tibotec BVBA | Study Director |
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| Label | URL |
|---|---|
| An Open-Label, Prospective, Non-Comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia. | View source |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C493870 | bedaquiline |
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| 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours |
| Area under curve extrapolated to infinity of N-monodesmethyl metabolite | 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |