Trial Outcomes & Findings for Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive. (NCT NCT02281448)
NCT ID: NCT02281448
Last Updated: 2014-12-03
Results Overview
Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
Results posted on
2014-12-03
Participant Flow
Participant milestones
| Measure |
Treatment Sequence A
oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive
BIA 2-093
Contraceptives, Oral, Combined
|
Treatment Sequence B
oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days
BIA 2-093
Contraceptives, Oral, Combined
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.
Baseline characteristics by cohort
| Measure |
Treatment Sequence A
n=10 Participants
oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive
BIA 2-093
Contraceptives, Oral, Combined
|
Treatment Sequence B
n=10 Participants
oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days
BIA 2-093
Contraceptives, Oral, Combined
|
Total
n=20 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
Outcome measures
| Measure |
Cmax (BIA 2-194)
n=17 Participants
Mean trough (pre-dose) plasma concentrations of BIA 2-194 on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
|
|---|---|
|
Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Day 1
|
0.00 ng/mL
Standard Deviation 0.00
|
|
Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Day 2
|
8443 ng/mL
Standard Deviation 1422
|
|
Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Day 4
|
10691 ng/mL
Standard Deviation 1736
|
|
Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Day 6
|
10961 ng/mL
Standard Deviation 1737
|
|
Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Day 8
|
10175 ng/mL
Standard Deviation 996
|
|
Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Day 10
|
10332 ng/mL
Standard Deviation 1470
|
|
Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Day 12
|
10821 ng/mL
Standard Deviation 1806
|
|
Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Day 14
|
10670 ng/mL
Standard Deviation 1447
|
|
Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Day 15
|
9978 ng/mL
Standard Deviation 1452
|
SECONDARY outcome
Timeframe: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
Outcome measures
| Measure |
Cmax (BIA 2-194)
n=17 Participants
Mean trough (pre-dose) plasma concentrations of BIA 2-194 on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
|
|---|---|
|
Cmax
Cmax (ethinyloestradiol) Test
|
53.4 pg/mL
Standard Deviation 17.9
|
|
Cmax
Cmax (ethinyloestradiol) Reference
|
66.1 pg/mL
Standard Deviation 19.1
|
|
Cmax
Cmax (Levonorgestrel) Test
|
3220 pg/mL
Standard Deviation 1330
|
|
Cmax
Cmax (Levonorgestrel) Reference
|
3720 pg/mL
Standard Deviation 1540
|
SECONDARY outcome
Timeframe: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
Outcome measures
| Measure |
Cmax (BIA 2-194)
n=17 Participants
Mean trough (pre-dose) plasma concentrations of BIA 2-194 on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
|
|---|---|
|
Tmax
tmax (ethinyloestradiol) Test
|
1.67 h
Standard Deviation 0.53
|
|
Tmax
tmax (ethinyloestradiol) Reference
|
1.52 h
Standard Deviation 0.21
|
|
Tmax
tmax (Levonorgestrel) Test
|
1.28 h
Standard Deviation 0.49
|
|
Tmax
tmax (Levonorgestrel) Reference
|
1.21 h
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
Outcome measures
| Measure |
Cmax (BIA 2-194)
n=17 Participants
Mean trough (pre-dose) plasma concentrations of BIA 2-194 on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
|
|---|---|
|
AUC0-t
AUC0-t (ethinyloestradiol) Test
|
347 pg.h/mL
Standard Deviation 145
|
|
AUC0-t
AUC0-t (ethinyloestradiol) Reference
|
595 pg.h/mL
Standard Deviation 639
|
|
AUC0-t
AUC0-t (Levonorgestrel) Test
|
24000 pg.h/mL
Standard Deviation 12100
|
|
AUC0-t
AUC0-t (Levonorgestrel) Reference
|
33600 pg.h/mL
Standard Deviation 20000
|
Adverse Events
Eslicarbazepine Acetate 1200 mg + Microginon®
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Microginon®
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eslicarbazepine Acetate 1200 mg + Microginon®
n=19 participants at risk；n=20 participants at risk
Eslicarbazepine acetate 1200 mg + Microginon® (n=19)
|
Microginon®
n=18 participants at risk；n=20 participants at risk
Microginon® (n=18)
|
|---|---|---|
|
Infections and infestations
Abnormal values of neutrophils and white blood cells
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Other adverse events
| Measure |
Eslicarbazepine Acetate 1200 mg + Microginon®
n=19 participants at risk；n=20 participants at risk
Eslicarbazepine acetate 1200 mg + Microginon® (n=19)
|
Microginon®
n=18 participants at risk；n=20 participants at risk
Microginon® (n=18)
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
15.8%
3/19
|
0.00%
0/18
|
|
Eye disorders
Eyelid oedema
|
5.3%
1/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Abdominal colic
|
5.3%
1/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Change in bowel habits
|
5.3%
1/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Constipation
|
26.3%
5/19
|
5.6%
1/18
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
1/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Epigastric fullness
|
5.3%
1/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Gastroenteritis noninfectious
|
5.3%
1/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Nausea
|
26.3%
5/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Xerostomia
|
5.3%
1/19
|
0.00%
0/18
|
|
General disorders
Flu-like symptoms
|
5.3%
1/19
|
0.00%
0/18
|
|
General disorders
Increased thirst
|
15.8%
3/19
|
0.00%
0/18
|
|
General disorders
Thirst
|
5.3%
1/19
|
0.00%
0/18
|
|
Infections and infestations
Escherichia coli cystitis
|
0.00%
0/19
|
5.6%
1/18
|
|
Infections and infestations
Viral infection
|
5.3%
1/19
|
0.00%
0/18
|
|
Infections and infestations
Pharyngitis
|
5.3%
1/19
|
0.00%
0/18
|
|
Infections and infestations
Respiratory tract infection
|
5.3%
1/19
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Catheter site ecchymosis
|
15.8%
3/19
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Catheter site haematoma
|
5.3%
1/19
|
0.00%
0/18
|
|
Investigations
CPK increased
|
5.3%
1/19
|
0.00%
0/18
|
|
Investigations
Lymph node palpable
|
5.3%
1/19
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Concentration impairment
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Dizziness
|
52.6%
10/19
|
0.00%
0/18
|
|
Nervous system disorders
Facial paraesthesia
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Frontal headache
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Headache
|
21.1%
4/19
|
5.6%
1/18
|
|
Nervous system disorders
Incoordination
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Lightheadedness
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Paraesthesia lips
|
15.8%
3/19
|
0.00%
0/18
|
|
Nervous system disorders
Paraesthesia tongue
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Pre-syncope
|
0.00%
0/19
|
5.6%
1/18
|
|
Nervous system disorders
Somnolence
|
73.7%
14/19
|
0.00%
0/18
|
|
Nervous system disorders
Tremor of hands
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Vasovagal reaction
|
10.5%
2/19
|
5.6%
1/18
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/19
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.3%
1/19
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
5.3%
1/19
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Pain chest
|
5.3%
1/19
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
5.3%
1/19
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
5.3%
1/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Acneiform eruption
|
5.3%
1/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Erythema facial
|
5.3%
1/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Erythematous eruption
|
5.3%
1/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Erythematous rash
|
10.5%
2/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Generalized macular rash
|
5.3%
1/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Localized erythema
|
5.3%
1/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.3%
1/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/19
|
5.6%
1/18
|
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