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Trial Outcomes & Findings for Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites (NCT NCT01515891)

NCT ID: NCT01515891

Last Updated: 2015-01-09

Results Overview

Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

4 participants

Primary outcome timeframe

24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose

Results posted on

2015-01-09

Participant Flow

Participant milestones

Participant milestones
Measure
BIA 9-1067
90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose). BIA 9-1067: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
Overall Study
STARTED
4
Overall Study
COMPLETED
4
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
BIA 9-1067
n=4 Participants
90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose). BIA 9-1067: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose

Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites

Outcome measures

Outcome measures
Measure
BIA 9-1067
n=4 Participants
90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose). BIA 9-1067: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
Maximum Plasma Concentration (Cmax)
482.98 ng-eq/mL
Standard Deviation 265.26

SECONDARY outcome

Timeframe: 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose

Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites

Outcome measures

Outcome measures
Measure
BIA 9-1067
n=4 Participants
90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose). BIA 9-1067: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
Time to Reach Maximum Plasma Concentration (Tmax)
1.69 hours
Standard Deviation 0.75

SECONDARY outcome

Timeframe: 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose

Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites

Outcome measures

Outcome measures
Measure
BIA 9-1067
n=4 Participants
90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose). BIA 9-1067: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t)
14038.27 h⋅ng-eq/mL
Standard Deviation 4823.78

SECONDARY outcome

Timeframe: 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose

Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites

Outcome measures

Outcome measures
Measure
BIA 9-1067
n=4 Participants
90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose). BIA 9-1067: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞)
33441.69 h⋅ng-eq/mL
Standard Deviation 14069.06

Adverse Events

BIA 9-1067

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
BIA 9-1067
n=4 participants at risk
90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose). BIA 9-1067: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
General disorders
Tiredness
50.0%
2/4
Nervous system disorders
Headache
50.0%
2/4
Gastrointestinal disorders
Flatulence
25.0%
1/4
Gastrointestinal disorders
Loose stools
25.0%
1/4

Additional Information

Head of Clinical Research

Bial - Portela & Cª, S.A.

Phone: +351 229 866 100

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER