Trial Outcomes & Findings for Analysis of Crushed and Whole Tablet Genvoya (NCT NCT03717129)
NCT ID: NCT03717129
Last Updated: 2023-01-31
Results Overview
AUC 0 to Infinity for Elvitegravir (ng\*h/mL)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
72 hours
Results posted on
2023-01-31
Participant Flow
This is a cross-over study where participants acted as their own controls. All participants received Genvoya oral first, and then crossed over to Genvoya crushed after a 2-week washout period.
Participant milestones
| Measure |
Genvoya Oral Dose
Single observed oral dose of Genvoya whole tablet
Genvoya Oral dose: Single Genvoya oral dose directly observed
|
|---|---|
|
Genvoya Oral Dose (1 Week)
STARTED
|
12
|
|
Genvoya Oral Dose (1 Week)
COMPLETED
|
12
|
|
Genvoya Oral Dose (1 Week)
NOT COMPLETED
|
0
|
|
Washout (2 Weeks)
STARTED
|
12
|
|
Washout (2 Weeks)
COMPLETED
|
12
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
|
Genvoya Crushed Dose (1 Week)
STARTED
|
12
|
|
Genvoya Crushed Dose (1 Week)
COMPLETED
|
12
|
|
Genvoya Crushed Dose (1 Week)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analysis of Crushed and Whole Tablet Genvoya
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
All participants received Genvoya Oral Dose and then, after a washout period, received Genvoya Crushed Dose.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 72 hoursAUC 0 to Infinity for Elvitegravir (ng\*h/mL)
Outcome measures
| Measure |
Genvoya Oral Dose
n=12 Participants
Single observed oral dose of Genvoya whole tablet
Genvoya Oral dose: Single Genvoya oral dose directly observed
|
Genvoya Crushed Dose
n=12 Participants
Single observed oral dose of Genvoya crushed tablet
Genvoya Crushed Dose: Single Genvoya crushed tablet in water directly observed
|
|---|---|---|
|
Area Under the Curve From 0 to Infinity (AUC0-∞) for EVG
|
24219 ng*h/mL
Standard Deviation 6074
|
26948 ng*h/mL
Standard Deviation 5955
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: Data was not collected for this outcome
AUC 0 to Infinity for Cobicistat (ng\*h/mL)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 72 hoursAUC 0 to Infinity for Emtricitabine (ng\*h/mL)
Outcome measures
| Measure |
Genvoya Oral Dose
n=12 Participants
Single observed oral dose of Genvoya whole tablet
Genvoya Oral dose: Single Genvoya oral dose directly observed
|
Genvoya Crushed Dose
n=12 Participants
Single observed oral dose of Genvoya crushed tablet
Genvoya Crushed Dose: Single Genvoya crushed tablet in water directly observed
|
|---|---|---|
|
AUC0-∞ for FTC
|
11603 ng*h/mL
Standard Deviation 2296
|
10969 ng*h/mL
Standard Deviation 1818
|
PRIMARY outcome
Timeframe: 72 hoursAUC 0 to Infinity for TFV (ng\*h/mL)
Outcome measures
| Measure |
Genvoya Oral Dose
n=12 Participants
Single observed oral dose of Genvoya whole tablet
Genvoya Oral dose: Single Genvoya oral dose directly observed
|
Genvoya Crushed Dose
n=12 Participants
Single observed oral dose of Genvoya crushed tablet
Genvoya Crushed Dose: Single Genvoya crushed tablet in water directly observed
|
|---|---|---|
|
AUC0-∞ for Tenofovir (TFV)
|
253 ng*h/mL
Standard Deviation 47
|
241 ng*h/mL
Standard Deviation 46
|
SECONDARY outcome
Timeframe: 72 HrMaximum Plasma Concentration (Cmax) for Elvitegravir (ng/mL)
Outcome measures
| Measure |
Genvoya Oral Dose
n=12 Participants
Single observed oral dose of Genvoya whole tablet
Genvoya Oral dose: Single Genvoya oral dose directly observed
|
Genvoya Crushed Dose
n=12 Participants
Single observed oral dose of Genvoya crushed tablet
Genvoya Crushed Dose: Single Genvoya crushed tablet in water directly observed
|
|---|---|---|
|
EVG Cmax
|
1650 ng/mL
Standard Deviation 371
|
1946 ng/mL
Standard Deviation 545
|
SECONDARY outcome
Timeframe: 72 hrMaximum Plasma Concentration (Cmax) for Emtricitabine (ng/mL)
Outcome measures
| Measure |
Genvoya Oral Dose
n=12 Participants
Single observed oral dose of Genvoya whole tablet
Genvoya Oral dose: Single Genvoya oral dose directly observed
|
Genvoya Crushed Dose
n=12 Participants
Single observed oral dose of Genvoya crushed tablet
Genvoya Crushed Dose: Single Genvoya crushed tablet in water directly observed
|
|---|---|---|
|
FTC Cmax
|
2095 ng/mL
Standard Deviation 445
|
1968 ng/mL
Standard Deviation 481
|
SECONDARY outcome
Timeframe: 72 hrMaximum Plasma Concentration (Cmax) for Tenofovir (ng/mL)
Outcome measures
| Measure |
Genvoya Oral Dose
n=12 Participants
Single observed oral dose of Genvoya whole tablet
Genvoya Oral dose: Single Genvoya oral dose directly observed
|
Genvoya Crushed Dose
n=12 Participants
Single observed oral dose of Genvoya crushed tablet
Genvoya Crushed Dose: Single Genvoya crushed tablet in water directly observed
|
|---|---|---|
|
TFV Cmax
|
11 ng/mL
Standard Deviation 4.1
|
9.5 ng/mL
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 72 hoursTerminal elimination half-life for EVG (hours).
Outcome measures
| Measure |
Genvoya Oral Dose
n=12 Participants
Single observed oral dose of Genvoya whole tablet
Genvoya Oral dose: Single Genvoya oral dose directly observed
|
Genvoya Crushed Dose
n=12 Participants
Single observed oral dose of Genvoya crushed tablet
Genvoya Crushed Dose: Single Genvoya crushed tablet in water directly observed
|
|---|---|---|
|
EVG Half-life
|
5 hours
Standard Deviation 0.52
|
5.1 hours
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Data was not collected for this outcome.
Terminal elimination half-life for COBI (hours)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 hoursTerminal elimination half-life for FTC (hours).
Outcome measures
| Measure |
Genvoya Oral Dose
n=12 Participants
Single observed oral dose of Genvoya whole tablet
Genvoya Oral dose: Single Genvoya oral dose directly observed
|
Genvoya Crushed Dose
n=12 Participants
Single observed oral dose of Genvoya crushed tablet
Genvoya Crushed Dose: Single Genvoya crushed tablet in water directly observed
|
|---|---|---|
|
FTC Half-life
|
15.2 hours
Standard Deviation 5.2
|
16.1 hours
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 72 hoursTerminal elimination half-life for TFV (hours).
Outcome measures
| Measure |
Genvoya Oral Dose
n=12 Participants
Single observed oral dose of Genvoya whole tablet
Genvoya Oral dose: Single Genvoya oral dose directly observed
|
Genvoya Crushed Dose
n=12 Participants
Single observed oral dose of Genvoya crushed tablet
Genvoya Crushed Dose: Single Genvoya crushed tablet in water directly observed
|
|---|---|---|
|
TFV Half-life
|
42.5 hours
Standard Deviation 6.7
|
40.7 hours
Standard Deviation 13.9
|
Adverse Events
Genvoya Oral Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genvoya Crushed Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place