Trial Outcomes & Findings for Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules (NCT NCT02071823)
NCT ID: NCT02071823
Last Updated: 2015-01-09
Results Overview
Cmax - Maximum observed plasma concentration of BIA 9-1067
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 1
Results posted on
2015-01-09
Participant Flow
Participant milestones
| Measure |
Group A Fed/Fasted
A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fed Washout Period (7days) Period 2: Fasted
BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.
|
Group B Fasted/Fed
A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fasted Washout Period (7days) Period 2: Fed
BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules
Baseline characteristics by cohort
| Measure |
Group A Fed/Fasted
n=6 Participants
A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fed Washout Period (7days) Period 2: Fasted
BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.
|
Group B Fasted/Fed
n=6 Participants
A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fasted Washout Period (7days) Period 2: Fed
BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Cmax - Maximum observed plasma concentration of BIA 9-1067
Outcome measures
| Measure |
Fasted Conditions
n=11 Participants
Fasted conditions period
|
Fed Condition
n=11 Participants
Fed condition period
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
|
635.0 ng/mL
Standard Deviation 250.8
|
238.2 ng/mL
Standard Deviation 168.4
|
PRIMARY outcome
Timeframe: Day 1AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067
Outcome measures
| Measure |
Fasted Conditions
n=11 Participants
Fasted conditions period
|
Fed Condition
n=11 Participants
Fed condition period
|
|---|---|---|
|
AUCt - Cumulative Area Under the Plasma Concentration Time Curve
|
879.2 ng·h/mL
Standard Deviation 286.6
|
1989.5 ng·h/mL
Standard Deviation 984.8
|
PRIMARY outcome
Timeframe: Day 1Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067
Outcome measures
| Measure |
Fasted Conditions
n=11 Participants
Fasted conditions period
|
Fed Condition
n=11 Participants
Fed condition period
|
|---|---|---|
|
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞)
|
2113.6 ng·h/mL
Standard Deviation 915.2
|
1027.2 ng·h/mL
Standard Deviation 545.4
|
Adverse Events
Fasted Conditions
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Fed Condition
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fasted Conditions
n=11 participants at risk
Fasted conditions period
|
Fed Condition
n=12 participants at risk
Fed condition period
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
18.2%
2/11
|
33.3%
4/12
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/11
|
8.3%
1/12
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11
|
8.3%
1/12
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/11
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
9.1%
1/11
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
9.1%
1/11
|
0.00%
0/12
|
Additional Information
Head of Clinical Research
Bial - Portela & Cª, S.A.
Phone: +351 229 866 100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER