Trial Outcomes & Findings for Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects (NCT NCT02092168)
NCT ID: NCT02092168
Last Updated: 2015-01-14
Results Overview
Cmax (BIA 9-1067) - maximum plasma concentration of BIA 9-1067
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 1 and Day 7
Results posted on
2015-01-14
Participant Flow
Participant milestones
| Measure |
BIA 9-1067 30 mg (QD) - Elderly Subjects
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (QD) - Elderly Subjects
|
BIA 9-1067 30 mg (QD) - Young Subjects
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (QD) - Young Subjects
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects
Baseline characteristics by cohort
| Measure |
BIA 9-1067 30 mg (Once Daily) - Elderly Subjects
n=12 Participants
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Elderly Subjects
|
BIA 9-1067 30 mg (Once Daily) - Young Subjects
n=12 Participants
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Young Subjects
|
Total
n=24 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
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 7Cmax (BIA 9-1067) - maximum plasma concentration of BIA 9-1067
Outcome measures
| Measure |
BIA 9-1067 30 mg (Once Daily) - Elderly Subjects
n=12 Participants
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Elderly Subjects
|
BIA 9-1067 30 mg (Once Daily) - Young Subjects
n=12 Participants
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Young Subjects
|
|---|---|---|
|
Cmax - Maximum Plasma Concentration
Day 1
|
407.4 ng/mL
Standard Deviation 81.1
|
391.1 ng/mL
Standard Deviation 138.0
|
|
Cmax - Maximum Plasma Concentration
Day 7
|
439.6 ng/mL
Standard Deviation 127.5
|
382.0 ng/mL
Standard Deviation 146.6
|
PRIMARY outcome
Timeframe: Day 1 and Day 7Tmax - Time to reach maximum plasma concentration of BIA 9-1067
Outcome measures
| Measure |
BIA 9-1067 30 mg (Once Daily) - Elderly Subjects
n=12 Participants
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Elderly Subjects
|
BIA 9-1067 30 mg (Once Daily) - Young Subjects
n=12 Participants
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Young Subjects
|
|---|---|---|
|
Tmax - Time to Reach Cmax
Day 1
|
2.0 hours
Interval 1.0 to 4.0
|
2.2 hours
Interval 0.5 to 3.0
|
|
Tmax - Time to Reach Cmax
Day 7
|
2.3 hours
Interval 0.5 to 4.0
|
2.7 hours
Interval 1.5 to 4.0
|
PRIMARY outcome
Timeframe: Day 1 and Day 7AUC0-t - Area under the plasma concentration-time curve of BIA 9-1067 from time 0 to last observed concentration
Outcome measures
| Measure |
BIA 9-1067 30 mg (Once Daily) - Elderly Subjects
n=12 Participants
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Elderly Subjects
|
BIA 9-1067 30 mg (Once Daily) - Young Subjects
n=12 Participants
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Young Subjects
|
|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Day 1
|
1265.9 ng.h/mL
Standard Deviation 240.6
|
1204.1 ng.h/mL
Standard Deviation 474.7
|
|
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Day 7
|
1413.65 ng.h/mL
Standard Deviation 451.3
|
1112.3 ng.h/mL
Standard Deviation 338.4
|
Adverse Events
BIA 9-1067 30 mg (Once Daily) - Elderly Subjects
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BIA 9-1067 30 mg (Once Daily) - Young Subjects
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 9-1067 30 mg (Once Daily) - Elderly Subjects
n=12 participants at risk
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Elderly Subjects
|
BIA 9-1067 30 mg (Once Daily) - Young Subjects
n=12 participants at risk
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
BIA 9-1067 30 mg (once daily) - Young Subjects
|
|---|---|---|
|
General disorders
Influenza like illness
|
0.00%
0/12
|
8.3%
1/12
|
|
Infections and infestations
Bronchitis lymphangitis
|
0.00%
0/12
|
8.3%
1/12
|
|
Nervous system disorders
Headache
|
8.3%
1/12
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.3%
1/12
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12
|
8.3%
1/12
|
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