Trial Outcomes & Findings for Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects (NCT NCT00987558)
NCT ID: NCT00987558
Last Updated: 2015-01-13
Results Overview
Simvastatin (Reference) ESL + Simvastatin (Test)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Day 1 and Day 14
Results posted on
2015-01-13
Participant Flow
Participant milestones
| Measure |
Simvastatin, Then ESL + Simvastatin
Simvastatin 80 mg - Oral single-dose administered alone Washout period - 3 weeks Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day
|
ESL, Then Simvastatin
Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day Washout period - 3 weeks Simvastatin 80 mg - Oral single-dose administered alone
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
17
|
|
Overall Study
Simvastatin
|
13
|
12
|
|
Overall Study
Washout
|
13
|
12
|
|
Overall Study
Eslicarbazepine Acetate + Simvastatin
|
13
|
17
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Eslicarbazepine Acetate + Simvastatin
n=30 Participants
Simvastatin 80 mg + eslicarbazepine acetate 800 mg
Simvastatin + ESL: Oral single-dose of simvastatin 80 mg on two occasions - once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days - separated by a washout period of 3 weeks or more.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 14Simvastatin (Reference) ESL + Simvastatin (Test)
Outcome measures
| Measure |
Simvastatin (Reference)
n=24 Participants
Simvastatin 80 mg
|
ESL + Simvastatin (Test)
n=24 Participants
Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
|
|---|---|---|
|
Simvastatin Cmax (Maximum Plasma Concentration)
|
17.7 ng/mL
Standard Deviation 14.0
|
6.89 ng/mL
Standard Deviation 5.21
|
PRIMARY outcome
Timeframe: Day 1 and Day 14Simvastatin (Reference) ESL + Simvastatin (Test)
Outcome measures
| Measure |
Simvastatin (Reference)
n=24 Participants
Simvastatin 80 mg
|
ESL + Simvastatin (Test)
n=24 Participants
Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
|
|---|---|---|
|
Simvastatin Tmax (Time of Occurrence of Cmax)
|
1.50 hours
Standard Deviation 3.29
|
1.62 hours
Standard Deviation 3.40
|
PRIMARY outcome
Timeframe: Day 1 and Day 14AUC0-t - area under the plasma concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification Simvastatin (Reference) ESL + Simvastatin (Test)
Outcome measures
| Measure |
Simvastatin (Reference)
n=24 Participants
Simvastatin 80 mg
|
ESL + Simvastatin (Test)
n=24 Participants
Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
|
|---|---|---|
|
Simvastatin AUC0-t
|
93.9 ng.h/mL
Standard Deviation 47.7
|
43.3 ng.h/mL
Standard Deviation 22.5
|
PRIMARY outcome
Timeframe: Day 1 and Day 14Simvastatin (Reference) ESL + Simvastatin (Test)
Outcome measures
| Measure |
Simvastatin (Reference)
n=24 Participants
Simvastatin 80 mg
|
ESL + Simvastatin (Test)
n=24 Participants
Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
|
|---|---|---|
|
Simvastatin AUC0-∞ (AUC From Time Zero to Infinity)
|
108 ng.h/mL
Standard Deviation 68.6
|
54.6 ng.h/mL
Standard Deviation 46.6
|
Adverse Events
Simvastatin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Eslicarbazepine Acetate
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Eslicarbazepine Acetate + Simvastatin
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 |
Simvastatin
n=30 participants at risk
Simvastatin 80 mg
|
Eslicarbazepine Acetate
n=30 participants at risk
eslicarbazepine acetate 800 mg
|
Eslicarbazepine Acetate + Simvastatin
n=30 participants at risk
Simvastatin 80 mg + eslicarbazepine acetate 800 mg
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
General disorders
Asthenia
|
0.00%
0/30
|
6.7%
2/30
|
0.00%
0/30
|
|
General disorders
Fatigue
|
0.00%
0/30
|
40.0%
12/30
|
0.00%
0/30
|
|
Infections and infestations
Cystitis
|
3.3%
1/30
|
0.00%
0/30
|
0.00%
0/30
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/30
|
0.00%
0/30
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Investigations
Transaminases increased
|
0.00%
0/30
|
0.00%
0/30
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Dizziness postural
|
3.3%
1/30
|
0.00%
0/30
|
0.00%
0/30
|
|
Nervous system disorders
Headache
|
3.3%
1/30
|
20.0%
6/30
|
6.7%
2/30
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/30
|
6.7%
2/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/30
|
10.0%
3/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/30
|
6.7%
2/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/30
|
3.3%
1/30
|
0.00%
0/30
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/30
|
0.00%
0/30
|
10.0%
3/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER