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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1439-051 | Other Identifier | Merck Protocol Number |
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This study will evaluate the effect of severe renal impairment on the pharmacokinetics of doravirine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe Renal Impairment | Experimental | Participants with severe renal impairment receive a single oral dose of 100 mg doravirine |
|
| Healthy Matched Control | Experimental | Healthy participants matched for age and weight receive a single oral dose of 100 mg doravirine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doravirine | Drug | Following an overnight fast, a single coated tablet of 100 mg doravirine will be administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
| Plasma Concentration of Doravirine at 24 Hours Postdose (C24) | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | 24 hours postdose |
| Maximum Observed Plasma Concentration (Cmax) of Doravirine | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
| Area Under the Plasma Concentration Versus Time Curve From 0 Hours to the Time of Last Quantifiable Sample of Doravirine (AUC 0-last) | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
| Time to Maximum Observed Plasma Concentration (Tmax) of Doravirine | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29891610 | Derived | Ankrom W, Yee KL, Sanchez RI, Adedoyin A, Fan L, Marbury T, Preston RA, Iwamoto M, Khalilieh SG. Severe Renal Impairment Has Minimal Impact on Doravirine Pharmacokinetics. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00326-18. doi: 10.1128/AAC.00326-18. Print 2018 Aug. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Severe Renal Impairment | Participants with severe renal impairment received a single oral dose of 100 mg doravirine |
| FG001 | Healthy Matched Controls | Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Severe Renal Impairment | Participants with severe renal impairment received a single oral dose of 100 mg doravirine |
| BG001 | Healthy Matched Controls | Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | μM•hr | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
|
Up to 14 days after drug administration
The population analyzed consisted of all participants who received at least 1 dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Severe Renal Impairment | Participants with severe renal impairment received a single oral dose of 100 mg doravirine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000592662 | doravirine |
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|
| Apparent Terminal Half-life (t1/2) of Plasma Doravirine | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
| Apparent Clearance of Plasma Doravirine After Extravascular Administration (CL/F) | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
| Apparent Volume of Distribution of Plasma Doravirine During the Terminal Phase (Vz/F) | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Weight | Mean | Standard Deviation | Kilogram |
|
| Healthy Matched Controls |
Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine |
|
|
|
| Primary | Plasma Concentration of Doravirine at 24 Hours Postdose (C24) | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | nM | 24 hours postdose |
|
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Doravirine | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 90% Confidence Interval | nM | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
|
|
|
|
| Primary | Area Under the Plasma Concentration Versus Time Curve From 0 Hours to the Time of Last Quantifiable Sample of Doravirine (AUC 0-last) | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | μM•hr | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
|
|
|
| Primary | Time to Maximum Observed Plasma Concentration (Tmax) of Doravirine | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Median | Full Range | Hours | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
|
|
|
| Primary | Apparent Terminal Half-life (t1/2) of Plasma Doravirine | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
|
|
|
| Primary | Apparent Clearance of Plasma Doravirine After Extravascular Administration (CL/F) | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
|
|
|
| Primary | Apparent Volume of Distribution of Plasma Doravirine During the Terminal Phase (Vz/F) | Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method. | All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Healthy Matched Control | Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine | 0 | 8 | 0 | 8 | 1 | 8 |
| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
Sponsor's policy on authorship is consistent with the requirements outlined in the ICH-Good Clinical Practice guidelines. In summary, authorship should reflect significant contribution to the design and conduct of the trial, performance or interpretation of the analysis, and/or writing of the manuscript.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |