Trial Outcomes & Findings for The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093 (NCT NCT02170649)

NCT ID: NCT02170649

Last Updated: 2017-05-08

Results Overview

Maximum observed plasma concentration of BIA 2-093

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
• Results posted on: 2017-05-08

Participant Flow

Participant milestones

Measure	BIA 2-093 (Fasting & Fed) 2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
Fasting Period STARTED	12
Fasting Period COMPLETED	12
Fasting Period NOT COMPLETED	0
Fed Period STARTED	12
Fed Period COMPLETED	12
Fed Period NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093

Baseline characteristics by cohort

Measure	Fasting Period n=12 Participants single 800 mg oral dose of BIA 2-093 following 10 hours of fasting or following either a standard high fat content breakfast.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 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	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose

Maximum observed plasma concentration of BIA 2-093

Outcome measures

Measure	Single Group n=12 Participants 2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
Maximum Observed Plasma Concentration (Cmax) Fasting	11302 ng/mL Standard Deviation 1866
Maximum Observed Plasma Concentration (Cmax) Fed	12799 ng/mL Standard Deviation 1769

SECONDARY outcome

Timeframe: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose

Time of occurrence of Cmax of BIA 2-093

Outcome measures

Measure	Single Group n=12 Participants 2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
Time of Occurrence of Cmax (Tmax) Fasting	3.5 hours Interval 0.5 to 8.0
Time of Occurrence of Cmax (Tmax) Fed	4.0 hours Interval 0.5 to 8.0

SECONDARY outcome

Timeframe: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose

Area under the plasma concentration versus time curve from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t) of BIA 2-093

Outcome measures

Measure	Single Group n=12 Participants 2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification (AUC0-t) Fasting	243155 ng.h/mL Standard Deviation 31213
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification (AUC0-t) Fed	229350 ng.h/mL Standard Deviation 41366

SECONDARY outcome

Timeframe: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose

Area under the plasma concentration versus time curve from time zero to infinity (AUC0-oo) of BIA 2-093

Outcome measures

Measure	Single Group n=12 Participants 2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo) Fasting	243589 ng.h/mL Standard Deviation 31052
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo) Fed	242459 ng.h/mL Standard Deviation 32085

Adverse Events

Single Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Single Group n=12 participants at risk 2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
Gastrointestinal disorders Dyspepsia	8.3% 1/12
Gastrointestinal disorders Nausea	8.3% 1/12
Gastrointestinal disorders Odynophagia	16.7% 2/12
Gastrointestinal disorders Toothache	8.3% 1/12
Infections and infestations Gastroenteritis NOS	8.3% 1/12
Infections and infestations Rhinosinusitis	8.3% 1/12
Nervous system disorders Headache NOS	16.7% 2/12
Nervous system disorders Muscle contraction involuntary	8.3% 1/12
Nervous system disorders Nystagmus	8.3% 1/12
Nervous system disorders Paresthesia	8.3% 1/12
Musculoskeletal and connective tissue disorders Muscle fatigue	8.3% 1/12
Musculoskeletal and connective tissue disorders Myalgia of lower extremities	8.3% 1/12
Respiratory, thoracic and mediastinal disorders Dry cough	8.3% 1/12
Respiratory, thoracic and mediastinal disorders Rhinitis NOS	8.3% 1/12
Skin and subcutaneous tissue disorders Pruritus NOS	16.7% 2/12

Additional Information

Head of Clinical Research

Bial - Portela & Cª, S.A.

Phone: +351 229 866 100

Email: clinical.trials@bial.com

Results disclosure agreements

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

Restriction type: OTHER