Trial Outcomes & Findings for The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin (NCT NCT02172742)
NCT ID: NCT02172742
Last Updated: 2025-04-06
Results Overview
Cmax - Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose
Results posted on
2025-04-06
Participant Flow
Participant milestones
| Measure |
BIA 2-093 + Placebo
Period 1:
BIA 2-093 1200 mg with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
Period 2:
Placebo with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
|
Placebo + BIA 2-093
Period 1:
Placebo with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
Period 2:
BIA 2-093 1200 mg with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin
Baseline characteristics by cohort
| Measure |
BIA 2-093 + Placebo
n=7 Participants
Period 1:
BIA 2-093 1200 mg with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
Period 2:
Placebo with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
|
Placebo + BIA 2-093
n=6 Participants
Period 1:
Placebo with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
Period 2:
BIA 2-093 1200 mg with:
Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin
|
Total
n=13 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
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-doseCmax - Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin
Outcome measures
| Measure |
BIA 2-093 + Placebo
n=12 Participants
Both Groups:
Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093
|
|---|---|
|
Cmax - Maximum Steady-state Plasma Concentration
Cmax (BIA 2-005)
|
27571 ng/mL
Standard Deviation 8252
|
|
Cmax - Maximum Steady-state Plasma Concentration
Cmax (Digoxin) (Digoxin+Placebo)
|
2,350 ng/mL
Standard Deviation 1,034
|
|
Cmax - Maximum Steady-state Plasma Concentration
Cmax (Digoxin) (Digoxin+BIA 2-093)
|
1,909 ng/mL
Standard Deviation 0,596
|
SECONDARY outcome
Timeframe: Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-doseTime of Occurrence of Cmax Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin
Outcome measures
| Measure |
BIA 2-093 + Placebo
n=12 Participants
Both Groups:
Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093
|
|---|---|
|
Tmax - Time of Occurrence of Cmax at Steady-state
tmax (BIA 2-005)
|
2 hours
Interval 1.0 to 6.0
|
|
Tmax - Time of Occurrence of Cmax at Steady-state
tmax (Digoxin) (Digoxin+placebo)
|
1 hours
Interval 0.5 to 2.0
|
|
Tmax - Time of Occurrence of Cmax at Steady-state
tmax (Digoxin) (Digoxin+BIA 2-093)
|
1 hours
Interval 0.5 to 4.0
|
SECONDARY outcome
Timeframe: Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-doseSteady-state Area Under the Plasma Concentration-time Profile Over 24 h of BIA 2-005 (BIA 2-093 metabolite) and Digoxin
Outcome measures
| Measure |
BIA 2-093 + Placebo
n=12 Participants
Both Groups:
Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093
|
|---|---|
|
AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h
AUCτ (BIA 2-005)
|
370297 ng*h/mL
Standard Deviation 79388
|
|
AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h
AUCτ (Digoxin) (Digoxin+Placebo)
|
17607 ng*h/mL
Standard Deviation 5599
|
|
AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h
AUCτ (Digoxin) (Digoxin+BIA 2-093)
|
16595 ng*h/mL
Standard Deviation 3801
|
Adverse Events
BIA 2-093+Digoxin
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo+Digoxin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIA 2-093+Digoxin
n=13 participants at risk
BIA 2-093 + Digoxin
|
Placebo+Digoxin
n=13 participants at risk
Placebo + Digoxin
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
Other adverse events
| Measure |
BIA 2-093+Digoxin
n=13 participants at risk
BIA 2-093 + Digoxin
|
Placebo+Digoxin
n=13 participants at risk
Placebo + Digoxin
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
15.4%
2/13
|
0.00%
0/13
|
|
Nervous system disorders
Headache
|
23.1%
3/13
|
0.00%
0/13
|
|
Nervous system disorders
Lipothymia
|
0.00%
0/13
|
7.7%
1/13
|
|
Nervous system disorders
Mental impairment
|
30.8%
4/13
|
7.7%
1/13
|
|
Nervous system disorders
Somnolence
|
23.1%
3/13
|
0.00%
0/13
|
|
Nervous system disorders
Syncope vasovagal
|
7.7%
1/13
|
0.00%
0/13
|
|
Nervous system disorders
Taste bitter
|
15.4%
2/13
|
0.00%
0/13
|
|
Nervous system disorders
Tension headache
|
7.7%
1/13
|
15.4%
2/13
|
|
Nervous system disorders
Vasovagal reaction
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
Axillary pain
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
Fatigue
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
General unwell
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
Retrosternal pain
|
7.7%
1/13
|
7.7%
1/13
|
|
Gastrointestinal disorders
Abdominal distension & abdominal pain generalized
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Epigastric burning
|
7.7%
1/13
|
0.00%
0/13
|
|
Gastrointestinal disorders
Heartburn
|
7.7%
1/13
|
0.00%
0/13
|
|
Infections and infestations
Folliculitis
|
7.7%
1/13
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Generalized pruritus
|
7.7%
1/13
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Cervical pain
|
7.7%
1/13
|
0.00%
0/13
|
|
Vascular disorders
Hypertension worsened
|
7.7%
1/13
|
7.7%
1/13
|
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