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| ID | Type | Description | Link |
|---|---|---|---|
| TMC114IFD1004 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-003397-43 | EudraCT Number |
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The purpose of this study is to evaluate the single-dose Pharmacokinetic (PK) and bioequivalence of darunavir (DRV) in the presence of cobicistat (COBI) when administered as a scored fixed dose combination (FDC) tablet (DRV/COBI) compared to the co-administration as the separate available tablet formulations (DRV and COBI), under fed conditions in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive Treatment A (a single dose of darunavir [DRV]/cobicistat [COBI] as one fixed dose combination [FDC] tablet under fed condition on Day 1) as per assigned treatment sequence (Treatment sequence AB or BA). A washout period of at least 7 days will be maintained between each treatment period. |
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| Treatment B | Active Comparator | Participants will receive Treatment B (a single dose of DRV/COBI as separate tablets under fed condition on Day 1) as per assigned treatment sequence (Treatment sequence BA or AB). A washout period of at least 7 days will be maintained between each treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir | Drug | Participants will receive a single dose of Darunavir tablets orally as per assigned treatment sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Analyte Concentration (Cmax) of Darunavir (DRV) | Cmax is defined as the maximum observed analyte concentration of DRV. | Predose, up to 72 hours post dose (up to Day 4) |
| Area Under the Analyte Concentration-time Curve from time Zero to Last Quantifiable time (AUC[0-last]) of DRV | AUC(0-last) is the area under the analyte concentration-time curve from time zero to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation. | Predose, up to 72 hours post dose (up to Day 4) |
| Area Under the Analyte Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of DRV | AUC (0-infinity) is the area under the analyte concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z), wherein AUC(0-last) is area under the analyte concentration-time curve from time zero to last quantifiable time, Clast is the last observed measurable (non-BQL) concentration, and lambda(z) is elimination rate constant. | Predose, up to 72 hours post dose (up to Day 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 6 weeks |
| Cmax of Cobicistat (COBI) |
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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 Clinical Pharmacology Unit (located in ZNA Stuivenberg) | Antwerp | 2060 | Belgium |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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 |
|---|---|
| D000069454 | Darunavir |
| D000069547 | Cobicistat |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 |
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| Cobicistat | Drug | Participant will receive a single dose of Cobicistat tablets orally as per assigned treatment sequence. |
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| Darunavir/Cobicistat FDC | Drug | Participants will receive a single dose of darunavir and cobicistat FDC tablets orally as per assigned treatment sequence. |
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Cmax is defined as the maximum observed analyte concentration of COBI. |
| Predose, up to 72 hours post dose (up to Day 4) |
| Area Under the Analyte Concentration-time Curve from time Zero to Last Quantifiable time (AUC[0-last]) of COBI | AUC(0-last) is the area under the analyte concentration-time curve from time zero to the time of the last measurable (non-BQL) concentration, calculated by linear-linear trapezoidal summation. | Predose, up to 72 hours post dose (up to Day 4) |
| Area Under the Analyte Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of COBI | AUC (0-infinity) is the area under the analyte concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z), wherein AUC(0-last) is area under the analyte concentration-time curve from time zero to last quantifiable time, Clast is the last observed measurable (non-BQL) concentration, and lambda(z) is elimination rate constant. | Predose, up to 72 hours post dose (up to Day 4) |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |