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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8591-030 | Other Identifier | MSD |
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This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and female adult participants with moderate hepatic impairment and in healthy matched control participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Hepatic Impairment | Experimental | Participants receive a single dose of ISL 60 mg. |
|
| Healthy Controls | Experimental | Participants receive a single dose of ISL 60 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Islatravir | Drug | Two ISL 30 mg capsules taken by mouth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Islatravir (ISL) in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
| Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
| Maximum Concentration (Cmax) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
| Time to Maximum Concentration (Tmax) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Tmax of plasma ISL was expressed as a median. | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
| Apparent Terminal Half-Life (t½) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
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Inclusion Criteria:
Healthy Control Participants:
Hepatic Impairment Participants:
Healthy and Hepatic Impairment Participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami ( Site 0001) | Miami | Florida | 33014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40042304 | Result | Matthews RP, Patel M, Liu W, Liu Y, Rondon JC, Vargo RC, Stoch SA, Iwamoto M. Pharmacokinetics of islatravir in participants with moderate hepatic impairment. Antimicrob Agents Chemother. 2025 Apr 2;69(4):e0155324. doi: 10.1128/aac.01553-24. Epub 2025 Mar 5. |
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Male and females with moderate hepatic impairment between the ages of 18 and 75 years old (inclusive), and healthy matched controls were enrolled in this study
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Moderate Hepatic Impairment | Participants with moderate hepatic impairment received a single oral dose of 60 mg Islatravir administered in capsule form. |
| FG001 | Healthy Matched Control Participants | Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Moderate Hepatic Impairment | Participants with moderate hepatic impairment received a single oral dose of 60 mg Islatravir administered in capsule form. |
| BG001 | Healthy Matched Control Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Curve From Time 0 to Infinity (AUC0-inf) of Islatravir (ISL) in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | Hours*μmol/Liter | Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
|
Up to 28 days
All-cause mortality includes all allocated participants and safety includes all participants who received at least one 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 | Participants With Moderate Hepatic Impairment | Participants with moderate hepatic impairment received a single oral dose of 60 mg Islatravir administered in capsule form. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2021 | Jul 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C558823 | islatravir |
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| Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
| Apparent Total Clearance (CL/F) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100. | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100. | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
| Up to 28 days |
| Percentage of Participants Who Discontinued From the Study Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to 28 days |
| AUC0-inf of ISL Triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMC) | Participants were treated with ISL, and peripheral blood samples were collected from pre-dose up to 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Predose and 4, 24, 48, 96, 168, 240, 336, 408, 504, and 672 hours post-dose |
| AUC0-last of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected from pre-dose up to 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Predose and 4, 24, 48, 96, 168, 240, 336, 408, 504, and 672 hours post-dose |
| Cmax of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected from pre-dose up to 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Predose and 4, 24, 48, 96, 168, 240, 336, 408, 504, and 672 hours post-dose |
| Concentration at 24 Hours Post Dose (C24) of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected at 24 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | 24 hours post-dose |
| Concentration at 168 Hours Post Dose (C168) of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected at 168 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | 168 hours post-dose |
| Concentration at 672 Hours Post Dose (C672) of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected at 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | 672 hours post-dose |
| Tmax of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected from pre-dose up to 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The Tmax of ISL-TP was expressed as a median. | Predose and 4, 24, 48, 96, 168, 240, 336, 408, 504, and 672 hours post-dose |
| T1/2 of ISL-TP in PBMC | Participants were treated with ISL, and peripheral blood samples were collected from pre-dose to 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100. | Predose and 4, 24, 48, 96, 168, 240, 336, 408, 504, and 672 hours post-dose |
Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants with moderate hepatic impairment received a single oral dose of 60 mg Islatravir administered in capsule form.
| OG001 | Healthy Matched Control Participants | Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form. |
|
|
|
| Primary | Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | Hours*μmol/Liter | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
|
|
|
|
| Primary | Maximum Concentration (Cmax) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | μmol/Liter | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
|
|
|
|
| Primary | Time to Maximum Concentration (Tmax) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Tmax of plasma ISL was expressed as a median. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Median | Full Range | Hours | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
|
|
|
| Primary | Apparent Terminal Half-Life (t½) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
|
|
|
| Primary | Apparent Total Clearance (CL/F) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/Hour | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
|
|
|
| Primary | Apparent Volume of Distribution During Terminal Phase (Vz/F) of ISL in Plasma | Participants were treated with ISL, and blood samples were collected from pre-dose up to 168 hours post-dose to determine the concentration of plasma ISL. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Pre-dose and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 168 hours post-dose |
|
|
|
| Secondary | Percentage of Participants With an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | All participants who received at least one dose of treatment. | Posted | Number | Percentage of participants | Up to 28 days |
|
|
|
| Secondary | Percentage of Participants Who Discontinued From the Study Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | All participants who received at least one dose of treatment. | Posted | Number | Percentage of participants | Up to 28 days |
|
|
|
| Secondary | AUC0-inf of ISL Triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMC) | Participants were treated with ISL, and peripheral blood samples were collected from pre-dose up to 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | hours*μmol/Liter | Predose and 4, 24, 48, 96, 168, 240, 336, 408, 504, and 672 hours post-dose |
|
|
|
|
| Secondary | AUC0-last of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected from pre-dose up to 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | hours*μmol/Liter | Predose and 4, 24, 48, 96, 168, 240, 336, 408, 504, and 672 hours post-dose |
|
|
|
|
| Secondary | Cmax of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected from pre-dose up to 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | μmol/Liter | Predose and 4, 24, 48, 96, 168, 240, 336, 408, 504, and 672 hours post-dose |
|
|
|
|
| Secondary | Concentration at 24 Hours Post Dose (C24) of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected at 24 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | μmol/Liter | 24 hours post-dose |
|
|
|
|
| Secondary | Concentration at 168 Hours Post Dose (C168) of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected at 168 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | μmol/Liter | 168 hours post-dose |
|
|
|
|
| Secondary | Concentration at 672 Hours Post Dose (C672) of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected at 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The 95% confidence interval was derived from a fixed effects model performed on natural log-transformed values. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | μmol/Liter | 672 hours post-dose |
|
|
|
|
| Secondary | Tmax of ISL-TP in PBMC | Participants were treated with ISL and peripheral blood samples were collected from pre-dose up to 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The Tmax of ISL-TP was expressed as a median. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Median | Full Range | Hours | Predose and 4, 24, 48, 96, 168, 240, 336, 408, 504, and 672 hours post-dose |
|
|
|
| Secondary | T1/2 of ISL-TP in PBMC | Participants were treated with ISL, and peripheral blood samples were collected from pre-dose to 672 hours post-dose to determine the concentration of ISL-TP in PBMCs. The Geometric Coefficient of Variation was expressed as a percent (%CV), and is calculated from the square root of corresponding estimated variance obtained for each population in fixed effect model multiplied by 100. | Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of important protocol deviations. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Predose and 4, 24, 48, 96, 168, 240, 336, 408, 504, and 672 hours post-dose |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Healthy Matched Control Participants | Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form. | 0 | 6 | 0 | 6 | 1 | 6 |
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |