Trial Outcomes & Findings for Drug-Drug Interaction Between Rifampin and Fluvastatin (NCT NCT04029584)
NCT ID: NCT04029584
Last Updated: 2021-09-08
Results Overview
The primary outcome will be fluvastatin Area under the concentration vs time curve (AUC0-12h and AUC0-INF)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
AUC will be assessed over a 12 hour study at 0, 0.33, 0.67,1,1.5, 2, 2.5, 3, 4, 6, 9, 12h
Results posted on
2021-09-08
Participant Flow
Flyer on campus and Craiglist
During the uninduced and induced study interventions there were separate randomization procedures.
Participant milestones
| Measure |
Fluvastatin Alone First, Then Fluvastatin +IV Rifampin 600 mg
Subjects received one oral dose of fluvastatin (Lescol®) 20mg capsule.
|
Fluvastatin +IV Rifampin 600 mg First, Then Fluvastatin Alone
Subjects received one oral dose of fluvastatin (Lescol®) 20mg capsule immediately following a 30-min intravenous infusion of rifampin 600mg in 10ml Normal Saline.
|
|---|---|---|
|
Uninduced Study 1st Intervention (1 Day)
STARTED
|
4
|
6
|
|
Uninduced Study 1st Intervention (1 Day)
COMPLETED
|
4
|
6
|
|
Uninduced Study 1st Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Uninduced Washout (1 Day)
STARTED
|
4
|
6
|
|
Uninduced Washout (1 Day)
COMPLETED
|
4
|
6
|
|
Uninduced Washout (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Uninduced Study 2nd Intervention (1 Day)
STARTED
|
4
|
6
|
|
Uninduced Study 2nd Intervention (1 Day)
COMPLETED
|
4
|
6
|
|
Uninduced Study 2nd Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout Between (>1 Week)
STARTED
|
4
|
6
|
|
Washout Between (>1 Week)
COMPLETED
|
4
|
6
|
|
Washout Between (>1 Week)
NOT COMPLETED
|
0
|
0
|
|
Induced Study 1st Intervention (1 Day)
STARTED
|
2
|
8
|
|
Induced Study 1st Intervention (1 Day)
COMPLETED
|
2
|
8
|
|
Induced Study 1st Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Induced Washout (1 Day)
STARTED
|
2
|
8
|
|
Induced Washout (1 Day)
COMPLETED
|
2
|
8
|
|
Induced Washout (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Induced Study 2nd Intervention (1 Day)
STARTED
|
2
|
8
|
|
Induced Study 2nd Intervention (1 Day)
COMPLETED
|
2
|
8
|
|
Induced Study 2nd Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug-Drug Interaction Between Rifampin and Fluvastatin
Baseline characteristics by cohort
| Measure |
All Subjects
n=10 Participants
Subjects were randomized to one of two treatment groups: 1) a single oral dose of fluvastatin (Lescol®) 20 mg capsule or 2) a single oral dose of fluvastatin (Lescol®) 20 mg capsule immediately following a 30-min intravenous infusion of rifampin 600 mg in 10 mL normal saline.
|
|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Serum creatinine
|
0.79 mg/dL
STANDARD_DEVIATION 0.13 • n=5 Participants
|
PRIMARY outcome
Timeframe: AUC will be assessed over a 12 hour study at 0, 0.33, 0.67,1,1.5, 2, 2.5, 3, 4, 6, 9, 12hPopulation: healthy volunteer
The primary outcome will be fluvastatin Area under the concentration vs time curve (AUC0-12h and AUC0-INF)
Outcome measures
| Measure |
Fluvastatin Control
n=10 Participants
healthy volunteer take a single dose fluvastatin
|
Fluvastatin and IV Rifampin
n=10 Participants
Healthy volunteer takes a single IV rifampin prior to oral fluvastatin
|
Fluvastatin + Oral Rifampin Induction
n=10 Participants
Healthy volunteers who take oral rifampin for 5 days prior to oral fluvastatin
|
Fluvastatin +Oral Rifampin Induced +IV Rifampin
n=10 Participants
Healthy takes five days oral rifampin, and then take one oral dose of fluvastatin (Lescol®) 20mg capsule immediately following a 30-min intravenous infusion of rifampin 600mg in 10ml Normal Saline
|
|---|---|---|---|---|
|
AUC
AUC(0-12)
|
242 ng/mL·h
Standard Deviation 83
|
642 ng/mL·h
Standard Deviation 269
|
124 ng/mL·h
Standard Deviation 33.7
|
371 ng/mL·h
Standard Deviation 217
|
|
AUC
AUC(0-INF)
|
266 ng/mL·h
Standard Deviation 86
|
679 ng/mL·h
Standard Deviation 274
|
136 ng/mL·h
Standard Deviation 35.9
|
385 ng/mL·h
Standard Deviation 222
|
SECONDARY outcome
Timeframe: Cmax will be assessed over a 12 hour study period.Population: healthy volunteers
Secondary outcomes will include fluvastatin maximum plasma concentration (Cmax).
Outcome measures
| Measure |
Fluvastatin Control
n=10 Participants
healthy volunteer take a single dose fluvastatin
|
Fluvastatin and IV Rifampin
n=10 Participants
Healthy volunteer takes a single IV rifampin prior to oral fluvastatin
|
Fluvastatin + Oral Rifampin Induction
n=10 Participants
Healthy volunteers who take oral rifampin for 5 days prior to oral fluvastatin
|
Fluvastatin +Oral Rifampin Induced +IV Rifampin
n=10 Participants
Healthy takes five days oral rifampin, and then take one oral dose of fluvastatin (Lescol®) 20mg capsule immediately following a 30-min intravenous infusion of rifampin 600mg in 10ml Normal Saline
|
|---|---|---|---|---|
|
Cmax
|
176 ng/mL
Standard Deviation 149
|
447 ng/mL
Standard Deviation 342
|
87.8 ng/mL
Standard Deviation 37.3
|
379 ng/mL
Standard Deviation 446
|
SECONDARY outcome
Timeframe: Tmax will be assessed over a 12 hour study period.Population: healthy volunteer
Secondary outcomes will include time to Cmax (Tmax).
Outcome measures
| Measure |
Fluvastatin Control
n=10 Participants
healthy volunteer take a single dose fluvastatin
|
Fluvastatin and IV Rifampin
n=10 Participants
Healthy volunteer takes a single IV rifampin prior to oral fluvastatin
|
Fluvastatin + Oral Rifampin Induction
n=10 Participants
Healthy volunteers who take oral rifampin for 5 days prior to oral fluvastatin
|
Fluvastatin +Oral Rifampin Induced +IV Rifampin
n=10 Participants
Healthy takes five days oral rifampin, and then take one oral dose of fluvastatin (Lescol®) 20mg capsule immediately following a 30-min intravenous infusion of rifampin 600mg in 10ml Normal Saline
|
|---|---|---|---|---|
|
Tmax
|
1.20 hr
Standard Deviation 0.62
|
1.17 hr
Standard Deviation 0.72
|
1.28 hr
Standard Deviation 0.545
|
1.23 hr
Standard Deviation 0.960
|
Adverse Events
Uninduced Healthy Volunteer Fluvastatin Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Uninduced Healthy Volunteer Fluvastatin and Rifampin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hepatic Induced Healthy Volunteer Fluvastatin Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hepatic Induced Healthy Volunteer Fluvastatin and Rifampin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Leslie Benet, PhD
University of California, San Francisco
Phone: (415) 476-3853
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place