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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000898-12 | EudraCT Number |
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The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched, healthy controls with normal renal function. Each participant in the renal impairment groups will be matched for age (± 10 years), gender, and body mass index [BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m^2)] with a participant in the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe Renal Impairment | Experimental | Participants with severe renal impairment and matched healthy controls will receive a single dose of bictegravir. |
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| Moderate Renal Impairment | Experimental | Participants with moderate renal impairment and matched healthy controls will receive a single dose of bictegravir. |
|
| Mild Renal Impairment | Experimental | Participants with mild renal impairment and matched healthy controls will receive a single dose of bictegravir. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bictegravir | Drug | 75 mg tablet administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total) | AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
| PK Parameter: AUCinf of Bictegravir (Free) | Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant). | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
| PK Parameter: AUClast of Bictegravir (Total) | AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
| PK Parameter: AUClast of Bictegravir (Free) | Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant). | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
| PK Parameter: Cmax of Bictegravir (Total) | Cmax is defined as the maximum observed plasma concentration of drug. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
| PK Parameter: Cmax of Bictegravir (Free) | Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Treatment-emergent adverse events (TEAEs) are defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. | First dose date to Day 31 |
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Key Inclusion Criteria:
All Individuals:
Individuals with impaired renal function
Chronic stable renal impairment without recent clinical change
Healthy individuals
Key Exclusion Criteria:
All Individuals:
Individuals with impaired renal function
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avail Clinical Research | DeLand | Florida | 32720 | United States | ||
| Clinical Pharmacology of Miami, Inc. |
49 participants were screened. No participants were enrolled in the moderate or mild renal impairment adaptive cohorts as a review showed that PK data collected were sufficient to detect any differences between the 2 renal function groups.
Participants were enrolled at study sites in the United States and New Zealand. The first participant was screened on 17 April 2015. The last study visit occurred on 13 July 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Severe Renal Impairment | Participants with severe renal impairment (CrCl = 15 - 29 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions |
| FG001 | Normal Renal Function | Matched healthy control participants with normal renal function (CrCl ≥ 90 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Safety Analysis Set included participants who received the single dose of bictegravir.
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| ID | Title | Description |
|---|---|---|
| BG000 | Severe Renal Impairment | Participants with severe renal impairment (CrCl = 15 - 29 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions |
| BG001 | Normal Renal Function |
| 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 | Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total) | AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. | The PK Analysis Set included participants who took the single dose of bictegravir and had at least 1 nonmissing postdose concentration value for bictegravir. | Posted | Mean | Standard Deviation | h*ng/mL | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
|
First dose date to Day 31
The Safety Analysis Set included participants who received the single dose of bictegravir.
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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 (CrCl = 15 - 29 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| ID | Term |
|---|---|
| C000620396 | bictegravir |
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| Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
| Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities | A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 abnormality grade from the predose assessment and occurring after the predose visit and on or before the date of the administration of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant. Toxicity grade was defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening. | First dose date to Day 31 |
| Miami |
| Florida |
| 33014-3616 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Prism Clinical Research | Saint Paul | Minnesota | 55114 | United States |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | United States |
| Auckland Clinical Studies Limited | Grafton | Auckland | 1010 | New Zealand |
| Christchurch Clinical Studies Trust | Christchurch | 8011 | New Zealand |
Matched healthy control participants with normal renal function (CrCl ≥ 90 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
Matched healthy control participants with normal renal function (CrCl ≥ 90 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions |
|
|
|
| Primary | PK Parameter: AUCinf of Bictegravir (Free) | Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant). | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
|
|
|
|
| Primary | PK Parameter: AUClast of Bictegravir (Total) | AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
|
|
|
|
| Primary | PK Parameter: AUClast of Bictegravir (Free) | Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant). | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
|
|
|
|
| Primary | PK Parameter: Cmax of Bictegravir (Total) | Cmax is defined as the maximum observed plasma concentration of drug. | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
|
|
|
|
| Primary | PK Parameter: Cmax of Bictegravir (Free) | Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant). | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | ng/mL | Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 |
|
|
|
|
| Secondary | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Treatment-emergent adverse events (TEAEs) are defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. | The Safety Analysis Set included participants who received the single dose of study drug. | Posted | Number | percentage of participants | First dose date to Day 31 |
|
|
|
| Secondary | Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities | A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 abnormality grade from the predose assessment and occurring after the predose visit and on or before the date of the administration of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant. Toxicity grade was defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date to Day 31 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Normal Renal Function | Matched healthy control participants with normal renal function (CrCl ≥ 90 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions | 0 | 8 | 0 | 8 | 2 | 8 |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Grade 3 |
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| Grade 4 |
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