Status:
COMPLETED
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
Lead Sponsor:
Global Alliance for TB Drug Development
Conditions:
Multi-drug Resistant Tuberculosis
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
Detailed Description
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects. Each panel of 24 subjects will be randomized according to the same 4-sequence, 4-...
Eligibility Criteria
Inclusion
- Key
- Male or female. Females must not be pregnant or breastfeeding.
- Willing and able to comply with the contraception requirements.
- Between 19 and 50 years of age (inclusive) at the time of screening.
- Body mass index (BMI) between 18.50 and 32 kg/m2 (inclusive) and weighs a minimum of 50 kg.
- Key
Exclusion
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Vital signs at screening (measured sitting after a minimum 3 minutes rest) as follows: blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg or a heart rate lower than 40 bpm or higher than 99 bpm. Out-of-range vital signs may be repeated once.
- History or presence of allergic or adverse response to pretomanid or related drugs.
- Use of any drugs or treatment with any known drugs that are moderate or strong inducers or inhibitors of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) and/or P-gp, including St. John's Wort, within 30 days before the first dose of study medication, and that, in the Investigator's judgment, may impact subject safety or the validity of the study results.
- Female with a positive pregnancy test result.
- Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
- Hemoglobin \<10.0 g/dL.
- ALT (alanine transaminase) or AST (aspartate aminotransferase) \>2.0 x the upper limit of normal (ULN).
- Hyperbilirubinemia \>1.5 x ULN.
- History or presence of alcoholism or drug abuse within the past 2 years as determined by the Investigator to be clinically relevant.
- Any clinically significant electrocardiogram abnormality at Screening (as deemed by decision of the Investigator and the Study Sponsor's Medical Monitor).
- QTcF interval \>450 msec for males or \>470 msec for females at screening, Day -1, or Day 1 (pre-dose), or history of prolonged QT syndrome.
- Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure or terminal cancer).
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04309656
Start Date
January 14 2020
End Date
February 28 2020
Last Update
July 24 2024
Active Locations (1)
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1
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, United States, 78217