Trial Outcomes & Findings for Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin (NCT NCT01422369)
NCT ID: NCT01422369
Last Updated: 2012-07-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
16 Days
Results posted on
2012-07-13
Participant Flow
1st Subject Enrolled 20 April 2011 Last Subject Completed 10 June 2011
Participant milestones
| Measure |
All Subjects
All randomized subjects
|
|---|---|
|
NK-104 4mg QD
STARTED
|
28
|
|
NK-104 4mg QD
COMPLETED
|
28
|
|
NK-104 4mg QD
NOT COMPLETED
|
0
|
|
Prezista 800mg/100mg QD
STARTED
|
28
|
|
Prezista 800mg/100mg QD
COMPLETED
|
28
|
|
Prezista 800mg/100mg QD
NOT COMPLETED
|
0
|
|
NK-104 4mg QD & Prezista 800mg/100mg QD
STARTED
|
28
|
|
NK-104 4mg QD & Prezista 800mg/100mg QD
COMPLETED
|
27
|
|
NK-104 4mg QD & Prezista 800mg/100mg QD
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin
Baseline characteristics by cohort
| Measure |
All Subjects
n=28 Participants
All randomized subjects
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
30.5 years
STANDARD_DEVIATION 6.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 DaysPopulation: All subjects with measurable pharmacokinetic (PK) values.
Outcome measures
| Measure |
NK-104
n=27 Participants
NK-104 4mg once daily (QD)
|
|---|---|
|
NK-104 AUC
|
192.00 ng * h/mL
Standard Deviation 80.8
|
SECONDARY outcome
Timeframe: 16 DaysPopulation: All subjects who took at least one dose of study medication.
Outcome measures
| Measure |
NK-104
n=28 Participants
NK-104 4mg once daily (QD)
|
|---|---|
|
Number of Participants With at Least One Adverse Event.
|
2 Participants
|
Adverse Events
All Subjects
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Subjects
n=28 participants at risk
All randomized subjects
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28
|
|
Nervous system disorders
Paresthesia
|
3.6%
1/28
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
1/28
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28
|
|
Gastrointestinal disorders
Swollen tongue
|
3.6%
1/28
|
|
Nervous system disorders
Headache
|
10.7%
3/28
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.7%
3/28
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.7%
3/28
|
|
General disorders
Fatigue
|
7.1%
2/28
|
|
General disorders
Feeling cold
|
3.6%
1/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee May not publish.
- Publication restrictions are in place
Restriction type: OTHER