Trial Outcomes & Findings for A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054) (NCT NCT01000818)
NCT ID: NCT01000818
Last Updated: 2017-03-21
Results Overview
Area Under the Plasma Concentration-Time Curve and peak concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
12 hours postdose
Results posted on
2017-03-21
Participant Flow
Participants were recruited through Abbott Northwestern Hospital Infectious Diseases Clinic, Minneapolis, MN and Prism Research, St. Paul, MN, between June 2008 and March 2009.
A total of 18 participants were enrolled in the study.
Participant milestones
| Measure |
Raltegravir/Famotidine/Omeprazole
Period 1 - 400 mg Raltegravir x 1 day
Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day
Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days
|
|---|---|
|
Raltegravir
STARTED
|
18
|
|
Raltegravir
COMPLETED
|
18
|
|
Raltegravir
NOT COMPLETED
|
0
|
|
Famotidine + Raltegravir
STARTED
|
18
|
|
Famotidine + Raltegravir
COMPLETED
|
18
|
|
Famotidine + Raltegravir
NOT COMPLETED
|
0
|
|
Omeprazole + Raltegravir
STARTED
|
18
|
|
Omeprazole + Raltegravir
COMPLETED
|
18
|
|
Omeprazole + Raltegravir
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
Baseline characteristics by cohort
| Measure |
Raltegravir/Famotidine/Omeprazole
n=18 Participants
Period 1 - 400 mg Raltegravir x 1 day
Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day
Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days
|
|---|---|
|
Age, Continuous
|
49.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Height
|
176.6 Centimeters
n=5 Participants
|
|
Weight
|
85.7 Kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 hours postdosePopulation: Eighteen HIV-Infected Patients
Area Under the Plasma Concentration-Time Curve and peak concentration
Outcome measures
| Measure |
400 mg Raltegravir
n=18 Participants
Period 1 - 400 mg Raltegravir
|
20 mg Famotidine + 400 mg Raltegravir
n=18 Participants
Period 2 - 20 mg Famotidine + 400 mg Raltegravir
|
20 mg Omeprazole + 400 mg Raltegravir
n=18 Participants
Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
|
|---|---|---|---|
|
Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir
|
12.36 µM*hr
Interval 8.96 to 17.04
|
17.95 µM*hr
Interval 13.02 to 24.75
|
17.12 µM*hr
Interval 12.42 to 23.61
|
Adverse Events
Prestudy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
400 mg Raltegravir
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
20 mg Famotidine + 400 mg Raltegravir
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
20 mg Omeprazole + 400 mg Raltegravir
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prestudy
n=18 participants at risk
|
400 mg Raltegravir
n=18 participants at risk
Period 1 - 400 mg Raltegravir
|
20 mg Famotidine + 400 mg Raltegravir
n=18 participants at risk
Period 2 - 20 mg Famotidine + 400 mg Raltegravir
|
20 mg Omeprazole + 400 mg Raltegravir
n=18 participants at risk
Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
|
|---|---|---|---|---|
|
Cardiac disorders
Ruptured coronary artery plaque
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
Other adverse events
| Measure |
Prestudy
n=18 participants at risk
|
400 mg Raltegravir
n=18 participants at risk
Period 1 - 400 mg Raltegravir
|
20 mg Famotidine + 400 mg Raltegravir
n=18 participants at risk
Period 2 - 20 mg Famotidine + 400 mg Raltegravir
|
20 mg Omeprazole + 400 mg Raltegravir
n=18 participants at risk
Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abnormal feces
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/18
|
11.1%
2/18
|
0.00%
0/18
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/18
|
0.00%
0/18
|
0.00%
0/18
|
5.6%
1/18
|
|
Nervous system disorders
Headache
|
0.00%
0/18
|
5.6%
1/18
|
5.6%
1/18
|
0.00%
0/18
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER