Trial Outcomes & Findings for Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin (NCT NCT01057433)
NCT ID: NCT01057433
Last Updated: 2021-06-22
Results Overview
Area under the curve from start to elimination.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
0, 1, 2, 3, 4, 5, 6, 8, and 12 hours after dosing on days 19 and 24
Results posted on
2021-06-22
Participant Flow
Participant milestones
| Measure |
All Subjects
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Subjects
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
Baseline characteristics by cohort
| Measure |
All Subjects
n=24 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 8.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 8, and 12 hours after dosing on days 19 and 24Area under the curve from start to elimination.
Outcome measures
| Measure |
All Subjects
n=23 Participants
|
|---|---|
|
Area Under the Curve From Time 0 to Tau (AUC 0-τ)
|
113.92 ng•h/mL
Standard Deviation 53.80
|
Adverse Events
All Subjects
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Subjects
n=24 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
54.2%
13/24
|
|
Gastrointestinal disorders
Abdominal pain
|
41.7%
10/24
|
|
Gastrointestinal disorders
Nausea
|
33.3%
8/24
|
|
Gastrointestinal disorders
Anal hemorrhage
|
16.7%
4/24
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
4/24
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
3/24
|
|
Gastrointestinal disorders
Constipation
|
8.3%
2/24
|
|
Nervous system disorders
Headache
|
25.0%
6/24
|
|
Nervous system disorders
Dysgeusia
|
12.5%
3/24
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
3/24
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
8.3%
2/24
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
12.5%
3/24
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
8.3%
2/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee May not publish.
- Publication restrictions are in place
Restriction type: OTHER