At a glance
ClinicalIndex Comparison Record- ✓Male aged 18 to 45 years old
- ✓Body mass index 18.5-25 kg/m2
- ✓Healthy with normal vital signs (systolic BP 100-129 mm Hg, diastolic BP 70-89 mm Hg, heart rate 60-80 bpm)
- ✓Normal laboratory parameters (complete blood count, biochemistry, urinalysis, negative HIV/HBV/HCV/syphilis tests)
- ✕Aggravated allergic history or prior drug allergy
- ✕Chronic diseases of cardiovascular, respiratory, endocrine, ENT, GI, hepatic, renal, hematologic, or skin systems
- ✕Chronic eye diseases except mild to moderate myopia, hypermetropia, or astigmatism
- ✕GI surgery within 1 year (except appendectomy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-label Prospective Noncomparative Study of Safety, Tolerability and Pharmacokinetics of PBTZ169 After Single and Multiple Fasting Oral Administration in Increasing Doses in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating PBTZ169 - 40 mg, PBTZ169 - 80 mg, and 5 other interventions for Tuberculosis. Completed, enrolled 40 participants.
Detailed Summary
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after single and multiple oral administration
Study Details
Timeline
Interventions
40 mg of PBTZ169 (1 capsule) orally once in fasting state
80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days