Trial Outcomes & Findings for To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers (NCT NCT02690727)
NCT ID: NCT02690727
Last Updated: 2017-11-28
Results Overview
Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
up to 24 hours post-dose.
Results posted on
2017-11-28
Participant Flow
Participant milestones
| Measure |
RP6530: Fast Condition First, Then Fed Condition
Fast Condition first, then Fed Condition
RP6530: Single oral dose
|
RP6530: Fed Condition First, Then Fast Condition
Fed Condition first, then Fast Condition
RP6530: Single oral dose
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
RP6530: Fast Condition First, Then Fed Condition
Fast Condition first, then Fed Condition
RP6530: Single oral dose
|
RP6530: Fed Condition First, Then Fast Condition
Fed Condition first, then Fast Condition
RP6530: Single oral dose
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
Baseline Characteristics
To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
All Participants
n=18 Participants
A single dose of RP6530 following fasting and Fed condition
RP6530: Single oral dose
|
|---|---|
|
Age, Continuous
|
29 Years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
01 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=5 Participants
|
|
Weight
|
73.9 Kg
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Height
|
173.7 cm
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Body Mass Index
|
24.50 kg/m^2
STANDARD_DEVIATION 2.46 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 hours post-dose.Population: subjects who provided evaluable data for both treatments (Fasting and fed conditions)
Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.
Outcome measures
| Measure |
RP6530 in Fast Condition
n=14 Participants
A single dose of RP6530 following fast condition
RP6530: Single oral dose
|
RP6530 in Fed Condition
n=14 Participants
A single dose of RP6530 following fed condition
RP6530: Single oral dose
|
|---|---|---|
|
Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))
|
5277.01 nanogram*hour per millilitre (ng*h/mL)
Geometric Coefficient of Variation 33.4
|
6726.99 nanogram*hour per millilitre (ng*h/mL)
Geometric Coefficient of Variation 29.4
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Healthy volunteers
Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0
Outcome measures
| Measure |
RP6530 in Fast Condition
n=16 Participants
A single dose of RP6530 following fast condition
RP6530: Single oral dose
|
RP6530 in Fed Condition
n=16 Participants
A single dose of RP6530 following fed condition
RP6530: Single oral dose
|
|---|---|---|
|
Number of Participants Who Were Evaluated for Adverse Events
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: up to 24 hours post-dose.Population: Subjects who provided evaluable data for both treatments
Peak Plasma Concentration (Cmax)
Outcome measures
| Measure |
RP6530 in Fast Condition
n=14 Participants
A single dose of RP6530 following fast condition
RP6530: Single oral dose
|
RP6530 in Fed Condition
n=14 Participants
A single dose of RP6530 following fed condition
RP6530: Single oral dose
|
|---|---|---|
|
Pharmacokinetic Parameters
|
1311.77 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 42.0
|
1753.78 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 32.6
|
Adverse Events
RP6530 in Fast Condition
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
RP6530 in Fed Condition
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RP6530 in Fast Condition
n=16 participants at risk
A single dose of RP6530 following fast condition
RP6530: Single oral dose
|
RP6530 in Fed Condition
n=16 participants at risk
A single dose of RP6530 following fed condition
RP6530: Single oral dose
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
6.2%
1/16 • Number of events 1 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
0.00%
0/16 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
|
Injury, poisoning and procedural complications
Vessel puncture site bleeding
|
12.5%
2/16 • Number of events 2 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
6.2%
1/16 • Number of events 1 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
|
Injury, poisoning and procedural complications
vessel puncture site swelling
|
6.2%
1/16 • Number of events 1 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
0.00%
0/16 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
|
Investigations
Hepatic enzyme increased
|
6.2%
1/16 • Number of events 1 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
12.5%
2/16 • Number of events 2 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
|
Investigations
Blood glucose increased
|
0.00%
0/16 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
6.2%
1/16 • Number of events 1 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
|
Investigations
Protein urine present
|
6.2%
1/16 • Number of events 1 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
0.00%
0/16 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
6.2%
1/16 • Number of events 1 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
0.00%
0/16 • Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study. 2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER