Trial Outcomes & Findings for Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide (NCT NCT01536366)
NCT ID: NCT01536366
Last Updated: 2015-08-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.
Results posted on
2015-08-20
Participant Flow
Participant milestones
| Measure |
Group 1
Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide
BIA 9-1067: 25 mg BIA 9-1067 (single-dose)
Repaglinide: 0.5 mg repaglinide (single-dose)
|
Group 2
Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide
BIA 9-1067: 25 mg BIA 9-1067 (single-dose)
Repaglinide: 0.5 mg repaglinide (single-dose)
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
BIA 9-1067 + Repaglinide
|
14
|
10
|
|
Overall Study
Repaglinide
|
14
|
13
|
|
Overall Study
Follow-up
|
13
|
9
|
|
Overall Study
COMPLETED
|
1
|
9
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide
Baseline characteristics by cohort
| Measure |
Group 1
n=14 Participants
Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide
BIA 9-1067: 25 mg BIA 9-1067 (single-dose)
Repaglinide: 0.5 mg repaglinide (single-dose)
|
Group 2
n=13 Participants
Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide
BIA 9-1067: 25 mg BIA 9-1067 (single-dose)
Repaglinide: 0.5 mg repaglinide (single-dose)
|
Total
n=27 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
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 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
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.Outcome measures
| Measure |
BIA 9-1067 + Repaglinide
n=24 Participants
BIA 9-1067 25 mg Repaglinide 0.5 mg
|
Repaglinide
n=27 Participants
Repaglinide 0.5 mg
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
BIA 9-1067
|
400 ng/mL
Standard Deviation 245.2
|
NA ng/mL
Standard Deviation NA
BIA 9-1067 was not administered.
|
|
Cmax - Maximum Observed Plasma Concentration
Repaglinide
|
11.6 ng/mL
Standard Deviation 5.22
|
9.76 ng/mL
Standard Deviation 5.42
|
SECONDARY outcome
Timeframe: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.Outcome measures
| Measure |
BIA 9-1067 + Repaglinide
n=24 Participants
BIA 9-1067 25 mg Repaglinide 0.5 mg
|
Repaglinide
n=27 Participants
Repaglinide 0.5 mg
|
|---|---|---|
|
Tmax - Time of Occurrence of Cmax
Repaglinide
|
0.5 hours
Interval 0.5 to 0.75
|
0.50 hours
Interval 0.5 to 3.0
|
|
Tmax - Time of Occurrence of Cmax
BIA 9-1067
|
2.00 hours
Interval 1.0 to 4.0
|
NA hours
BIA 9-1067 was not administered
|
SECONDARY outcome
Timeframe: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.Outcome measures
| Measure |
BIA 9-1067 + Repaglinide
n=24 Participants
BIA 9-1067 25 mg Repaglinide 0.5 mg
|
Repaglinide
n=27 Participants
Repaglinide 0.5 mg
|
|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
BIA 9-1067
|
979 ng.h/mL
Standard Deviation 607
|
NA ng.h/mL
Standard Deviation NA
BIA 9-1067 was not administered
|
|
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Repaglinide
|
14.2 ng.h/mL
Standard Deviation 4.96
|
13.1 ng.h/mL
Standard Deviation 5.33
|
SECONDARY outcome
Timeframe: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.Outcome measures
| Measure |
BIA 9-1067 + Repaglinide
n=24 Participants
BIA 9-1067 25 mg Repaglinide 0.5 mg
|
Repaglinide
n=27 Participants
Repaglinide 0.5 mg
|
|---|---|---|
|
AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity
Repaglinide
|
15.0 ng.h/mL
Standard Deviation 4.95
|
14.1 ng.h/mL
Standard Deviation 5.5
|
|
AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity
BIA 9-1067
|
1015 ng.h/mL
Standard Deviation 608
|
NA ng.h/mL
Standard Deviation NA
BIA 9-1067 was not administered
|
Adverse Events
BIA 9-1067 + Repaglinide
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Repaglinide
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 9-1067 + Repaglinide
n=24 participants at risk
BIA 9-1067 25 mg Repaglinide 0.5 mg
|
Repaglinide
n=27 participants at risk
Repaglinide 0.5 mg
|
|---|---|---|
|
Cardiac disorders
Presyncope
|
4.2%
1/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24
|
3.7%
1/27
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24
|
3.7%
1/27
|
|
General disorders
Influenza like illness
|
4.2%
1/24
|
0.00%
0/27
|
|
Infections and infestations
Cystitis
|
0.00%
0/24
|
3.7%
1/27
|
|
Infections and infestations
Oral herpes
|
4.2%
1/24
|
0.00%
0/27
|
|
Infections and infestations
Otitis externa
|
0.00%
0/24
|
3.7%
1/27
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/24
|
3.7%
1/27
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/24
|
3.7%
1/27
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Foot fracture
|
4.2%
1/24
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/24
|
3.7%
1/27
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
1/24
|
0.00%
0/27
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
1/24
|
0.00%
0/27
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/24
|
3.7%
1/27
|
|
Nervous system disorders
Headache
|
0.00%
0/24
|
3.7%
1/27
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24
|
0.00%
0/27
|
|
Vascular disorders
Hypotension
|
4.2%
1/24
|
3.7%
1/27
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/24
|
3.7%
1/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place