Status:
COMPLETED
Pharmacokinetics, Safety and Tolerability of Escalating Rifapentine Doses in Healthy Volunteers
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Sanofi
Centers for Disease Control and Prevention
Conditions:
Tuberculosis
Tuberculosis, Pulmonary
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The aim of this study is to evaluate (1) the safety and tolerability of escalating doses of rifapentine (RPT) administered daily by oral; (2) the effect of increasing doses of RPT on cytochrome P450 i...
Detailed Description
On day 1, volunteers will receive a single dose of MDZ dosed at 15 mg delivered orally, and a 24-hour PK analysis of MDZ and its metabolite, 1-OH-midazolam (1-OH-MDZ) will be performed. RPT (or RIF) w...
Eligibility Criteria
Inclusion
- Ability and willingness to provide written informed consent.
- Age greater than or equal to 18 years, and less than or equal to 65 years.
- Weight of 50-100 kg for enrollment into the RPT cohorts
- Weight of 50-80 kg for enrollment into the RIF cohort
- Within 28 or fewer days prior to enrollment, a complete blood count with differential, comprehensive serum chemistry profile, HIV antibody test, and Hepatitis C antibody test will be performed, with the following laboratory values:
- Serum amino aspartate transferase (AST) less than the upper limit of normal
- Total bilirubin level less than the upper limit of normal
- Serum creatinine \<1.5 mg/dL
- Hemoglobin greater than 12.0 for men, greater than 11.0 for women
- Platelet count greater than or equal to 125,000 /cu mm
- Absolute neutrophil count greater than or equal to 1250 /cu mm
- Serum albumin greater than 3.5 g/dL
- HIV antibody test negative
- Hepatitis C antibody negative
- For women of childbearing potential, a negative serum bHCG pregnancy test, performed at screening.
- During the study and for 14 days after the last dose of study medication, women of childbearing potential must agree to practice barrier contraception for the duration of the study.
Exclusion
- Pregnant or breastfeeding
- Known intolerance of or allergy to rifamycins
- Allergy to benzodiazepines
- Use of rifamycin antibiotics in the 30 days prior to enrollment
- Inability to take oral medications
- Renal, hepatic, cardiac (except benign heart murmur), or endocrine disorder; or malignancy; or immunocompromise.
- History of any acute or chronic illness that requires current medical therapy.
- Prior gastrointestinal surgery involving stomach, biliary system, pancreas, or small intestine.
- Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in the protocol.
- Any illicit drug use within the preceding 2 months. Subjects must agree to abstain from alcohol and illicit drug use during the study. Smokers must agree to abstain from cigarettes or to smoke fewer than 5 cigarettes per day.
- Current use of any prescription medication(s), including oral contraceptives.
- Planned use, during the study from Day 0 through the last PK blood draw, of any of the following: prescription medication(s), herbal supplement(s), vitamin(s), mineral supplement(s), over-the-counter medication(s), or grapefruit juice. Subjects must agree to abstain from grapefruit juice during the study.
- Participation in any other investigational drug study within 30 days prior to study entry and during study.
- Inability to participate in pharmacokinetic visits
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01162486
Start Date
April 1 2010
End Date
March 1 2011
Last Update
May 7 2019
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287