Trial Outcomes & Findings for An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites (NCT NCT02169427)

Results Overview

AEurine: Cumulative Recovery of \[14C\]-Radioactivity in urine AEfaeces: Cumulative Recovery of \[14C\]-Radioactivity in urine AEair: Cumulative Recovery of \[14C\]-Radioactivity in urine AEtotal: Cumulative Recovery of \[14C\]-Radioactivity in urine Recovery % of dose has been derived from area under the excretion rate (to infinity) from 240h onwards

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29

Results posted on

2015-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Opicapone (OPC) 100 mg OPC OPC: The drug substance of 100 mg OPC was administered as 1 capsule.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Opicapone (OPC) n=6 Participants 100 mg OPC OPC: The drug substance of 100 mg OPC was administered as 1 capsule.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 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	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29

AEurine: Cumulative Recovery of \[14C\]-Radioactivity in urine AEfaeces: Cumulative Recovery of \[14C\]-Radioactivity in urine AEair: Cumulative Recovery of \[14C\]-Radioactivity in urine AEtotal: Cumulative Recovery of \[14C\]-Radioactivity in urine Recovery % of dose has been derived from area under the excretion rate (to infinity) from 240h onwards

Outcome measures

Outcome measures
Measure	Opicapone (OPC) n=6 Participants 100 mg OPC OPC: The drug substance of 100 mg OPC was administered as 1 capsule.
Cumulative Recovery of [14C]-Radioactivity AEurine	12.8 Recovery % of dose Standard Deviation 1.5
Cumulative Recovery of [14C]-Radioactivity AEfaeces	67.2 Recovery % of dose Standard Deviation 7.6
Cumulative Recovery of [14C]-Radioactivity AEair	15.9 Recovery % of dose Standard Deviation 4.8
Cumulative Recovery of [14C]-Radioactivity AEtotal	95.9 Recovery % of dose Standard Deviation 8.6

SECONDARY outcome

Timeframe: pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29

BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite

Outcome measures

Outcome measures
Measure	Opicapone (OPC) n=6 Participants 100 mg OPC OPC: The drug substance of 100 mg OPC was administered as 1 capsule.
Cmax - Maximum Concentration 14C plasma	7302 ng [eq]/mL Standard Deviation 3918
Cmax - Maximum Concentration 14C blood	1920 ng [eq]/mL Standard Deviation 813
Cmax - Maximum Concentration OPC plasma	757 ng [eq]/mL Standard Deviation 321
Cmax - Maximum Concentration BIA 9-1103 plasma	118 ng [eq]/mL Standard Deviation 60.9

SECONDARY outcome

Timeframe: pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29

BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite

Outcome measures

Outcome measures
Measure	Opicapone (OPC) n=6 Participants 100 mg OPC OPC: The drug substance of 100 mg OPC was administered as 1 capsule.
Tmax - Time to Attain Maximum Concentration 14C plasma	0.51 hours Standard Deviation 0.01
Tmax - Time to Attain Maximum Concentration 14C blood	1.01 hours Standard Deviation 0.01
Tmax - Time to Attain Maximum Concentration OPC plasma	2.43 hours Standard Deviation 1.10
Tmax - Time to Attain Maximum Concentration BIA 9-1103 plasma	8.34 hours Standard Deviation 3.88

Adverse Events

Opicapone (OPC)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Opicapone (OPC) n=6 participants at risk 100 mg OPC OPC: The drug substance of 100 mg OPC was administered as 1 capsule.
Nervous system disorders Headache	16.7% 1/6
Nervous system disorders Somnolence	33.3% 2/6
Injury, poisoning and procedural complications Wound	16.7% 1/6
Gastrointestinal disorders Frequent Bowel Movements	16.7% 1/6

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