Trial Outcomes & Findings for Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers (NCT NCT02305017)

Results Overview

Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

Results posted on

2015-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Period 1 OPC + Paracetamol; Period 2 OPC Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC) BIA 9-1067: BIA 9-1067 50 mg Paracetamol: Paracetamol 1g	Period 1 OPC; Period 2 OPC+ Paracetamol Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol; BIA 9-1067: BIA 9-1067 50 mg Paracetamol: Paracetamol 1g
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Period 1 OPC + Paracetamol; Period 2 OPC n=14 Participants Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC) BIA 9-1067: BIA 9-1067 50 mg Paracetamol: Paracetamol 1g	Period 1 OPC; Period 2 OPC+ Paracetamol n=14 Participants Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol; BIA 9-1067: BIA 9-1067 50 mg Paracetamol: Paracetamol 1g	Total n=28 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	14 Participants n=5 Participants	14 Participants n=7 Participants	28 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	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration

Outcome measures

Outcome measures
Measure	Opicapone Alone n=28 Participants Opicapone, OPC, BIA 9-1079 alone	Opicapone Plus Paracetamol n=28 Participants Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
Cmax - Maximum Plasma Concentration	895 ng/mL Standard Deviation 375.9	986 ng/mL Standard Deviation 355

SECONDARY outcome

Timeframe: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

Tmax - time of occurrence of Cmax following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.

Outcome measures

Outcome measures
Measure	Opicapone Alone n=28 Participants Opicapone, OPC, BIA 9-1079 alone	Opicapone Plus Paracetamol n=28 Participants Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
Tmax - Time of Occurrence of Cmax	2.0 hours Interval 1.0 to 3.0	2.0 hours Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

AUC0-t - area under the plasma concentration-time curve (AUC) from time zero to the last sampling time following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration

Outcome measures

Outcome measures
Measure	Opicapone Alone n=28 Participants Opicapone, OPC, BIA 9-1079 alone	Opicapone Plus Paracetamol n=28 Participants Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification	2416 ng.h/mL Standard Deviation 884.3	2818 ng.h/mL Standard Deviation 1194

SECONDARY outcome

Timeframe: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

AUC0-∞ - AUC from time 0 to infinity following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.

Outcome measures

Outcome measures
Measure	Opicapone Alone n=28 Participants Opicapone, OPC, BIA 9-1079 alone	Opicapone Plus Paracetamol n=28 Participants Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.	2451 ng.h/mL Standard Deviation 882	2850 ng.h/mL Standard Deviation 1188

Adverse Events

Opicapone Alone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Opicapone Plus Paracetamol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Opicapone Alone n=28 participants at risk Opicapone, OPC, BIA 9-1079 alone	Opicapone Plus Paracetamol n=28 participants at risk Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
Infections and infestations Nasopharyngitis	0.00% 0/28	3.6% 1/28
Infections and infestations Tooth abscess	3.6% 1/28	0.00% 0/28

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