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| ID | Type | Description | Link |
|---|---|---|---|
| TMC278IFD1004 | Other Identifier | Janssen R&D Ireland |
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The purpose of the study is to evaluate the effect of steady-state (constant concentration of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is absorbed in the body, distributed within the body, and removed from the body) of a single dose of metformin, over time, in healthy adult participants.
This is a phase I, open-label (all people know the identity of the intervention) and sequential study (study medication is given in a sequence) in healthy participants, to investigate the pharmacokinetic interaction between steady-state rilpivirine and a single dose of metformin. The study consists of 3 phases including, the screening phase (28 days before enrollment), treatment phase (19 days), and the follow-up phase (7 days after the last intake of study medication). All participants will receive study medications in two sessions in a fixed, sequential order as a session 1 (a single dose of metformin on Day 1) followed by washout period (period when no treatment is received) of 4 days and then session 2 (rilpivirine on Day 5 to Day 17 with a single dose of metformin on Day 15). The duration of the study is approximately 54 days. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination (including skin examination) will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilpivirine+Metformin | Experimental | All participants will receive study medications in two sessions in a fixed, sequential order as a session 1 (a single dose of metformin on Day 1) followed by washout period (period when no treatment is received) of 4 days and then session 2 (rilpivirine on Day 5 to Day 17 with a single dose of metformin on Day 15). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Type=exact number, unit=mg, number=850, form=tablet, route=oral. Participants will receive single dose of metformin on Day 1 and Day 15. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma analyte concentration (Cmax) of metformin | Day 1 and Day 15 | |
| Actual sampling time to reach the maximum plasma analyte concentration (tmax) of metformin | Day 1 and Day 15 | |
| Area under curve from time of administration up to the last time point with a measurable plasma analyte concentration after dosing (AUClast) of metformin | Day 1 and Day 15 | |
| AUC extrapolated to infinity of metformin | AUC extrapolated to infinity, calculated as AUClast + Clast/apparent terminal elimination rate constant, where Clast is the last measurable plasma analyte concentration; extrapolations of more than 20 percent of the total AUC are reported as approximations. | Day 1 and Day 15 |
| Apparent terminal elimination rate constant of metformin | Apparent terminal elimination rate constant will be estimated by linear regression using the terminal log-linear phase of the logarithmic transformed conentration versus time data. | Day 1 and Day 15 |
| Apparent terminal elimination half-life of metformin | Day 1 and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Predose plasma analyte concentration (C0h) of rilpivirine | Day 12, Day 13, Day 14, Day 15, Day 17, Day 18 | |
| Minimum observed plasma analyte concentration (Cmin) of rilpivirine | Day 15 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen R&D Ireland Clinical Trial | Janssen R&D Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | United States |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000068696 | Rilpivirine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009570 |
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| Rilpivirine | Drug | Type=exact number, unit=mg, number=25, form=tablet route=oral. Participants will receive 1 tablet of rilpivirine from Day 5 to Day 17. |
|
| Maximum observed plasma analyte concentration (Cmax) of rilpivirine |
| Day 15 |
| Actual sampling time to reach the maximum plasma analyte concentration (tmax) of rilpivirine | Day 15 |
| Observed plasma analyte concentration at the end of the 24-hour dosing interval (C24h) | Day 15 |
| AUC from time of administration up to 24 hours after administration (AUC24h) | Day 15 |
| Average steady-state plasma concentration (Css,av) | Css,av is calculated by AUC dosing interval/dosing interval at steady-state | Day 15 |
| Fluctuation index (FI) | FI, percentage fluctuation is variation between maximum and minimum plasma concentration at steady-state | Day 15 |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 54 Days |
| Nitriles |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |