Trial Outcomes & Findings for Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers (NCT NCT00971295)

NCT ID: NCT00971295

Last Updated: 2014-12-16

Results Overview

Maximum Observed Plasma Metformin Concentration

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2014-12-16

Participant Flow

Participant milestones

Measure	Treatment Sequence A Treatment Sequence A: Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period 850 mg metformin hydrochloride, 1200 mg ESL	Treatment Sequence B Treatment Sequence B: Metformin period followed by washout period followed by Metformin + Eslicarbazepine acetate 850 mg metformin hydrochloride, 1200 mg ESL
Overall Study STARTED	10	10
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers

Baseline characteristics by cohort

Measure	Metformin + ESL n=20 Participants Metformin HCl 850 mg, ESL 1200 mg Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Maximum Observed Plasma Metformin Concentration

Outcome measures

Measure	Metformin + ESL n=20 Participants Metformin HCl 850 mg, ESL 1200 mg Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days	Metformin n=19 Participants Metformin HCl 850 mg
Cmax - Maximum Observed Plasma Concentration	1091 ng/mL Standard Deviation 27.6	1224 ng/mL Standard Deviation 21.9

SECONDARY outcome

Timeframe: 3 weeks

time of occurrence of maximum observed plasma metformin concentration

Outcome measures

Measure	Metformin + ESL n=20 Participants Metformin HCl 850 mg, ESL 1200 mg Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days	Metformin n=19 Participants Metformin HCl 850 mg
Tmax - Time of Occurrence of Cmax	2.66 hours Standard Deviation 46.9	2.53 hours Standard Deviation 40.4

SECONDARY outcome

Timeframe: 3 weeks

area under the plasma metformin concentration from time zero to infinity

Outcome measures

Measure	Metformin + ESL n=20 Participants Metformin HCl 850 mg, ESL 1200 mg Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days	Metformin n=19 Participants Metformin HCl 850 mg
AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity	7362 ng*h/mL Standard Deviation 26.7	7688 ng*h/mL Standard Deviation 21.4

Adverse Events

Metformin + ESL

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Metformin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metformin + ESL n=20 participants at risk Metformin HCl 850 mg, ESL 1200 mg Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days	Metformin n=20 participants at risk Metformin HCl 850 mg
Skin and subcutaneous tissue disorders Erythropapular rash	0.00% 0/20	5.0% 1/20
Nervous system disorders Vasovagal reaction	0.00% 0/20	5.0% 1/20
General disorders Constipation	5.0% 1/20	0.00% 0/20
Infections and infestations Herpes labialis	0.00% 0/20	5.0% 1/20
General disorders Right forearm ecchymosis	5.0% 1/20	0.00% 0/20
Nervous system disorders Recurrent vasovagal reaction	0.00% 0/20	5.0% 1/20
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/20	5.0% 1/20
Skin and subcutaneous tissue disorders Bilateral popliteal erythromacular rash	5.0% 1/20	0.00% 0/20
Nervous system disorders Headache	10.0% 2/20	0.00% 0/20
Skin and subcutaneous tissue disorders Eczema aggravated	5.0% 1/20	0.00% 0/20
Infections and infestations Acute gastroenteritis	5.0% 1/20	0.00% 0/20
Psychiatric disorders Anxiety	5.0% 1/20	0.00% 0/20
Injury, poisoning and procedural complications Eyelid hematoma	5.0% 1/20	0.00% 0/20

Additional Information

Head of Clinical Research

Bial - Portela & Cª, S.A.

Phone: +351 229 866 100

Email: jose.rocha@bial.com

Results disclosure agreements

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