NCT03776500

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PBTZ169 in Multiple Dosing

Safety, Tolerability and Pharmacokinetic Profile of PBTZ169 Formulated as Native Crystal Powder: Multiple Ascending Doses, Randomized, Placebo- Controlled, Parallel-group, Sequential Phase Ib Trial in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Innovative Medicines for Tuberculosis · Academic / Other
• Sex: Male
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in Switzerland. Four (4) panels (A, B, C and D) of 8 male subjects (6 active and 2 placebo) each receiving multiple doses of PBTZ169 or a matching placebo, at increasing dose levels, once or twice daily. Subjects will participate in only one panel. Blocks of 4 subjects (3 under active treatment, 1 under placebo) will be investigated in parallel. Panels will start sequentially. Safety will be assessed throughout the study; serial ECGs and serial blood samples will be collected for the safety and PK assessment of PBTZ169. Dose escalation will be allowed once the Trial Safety Board has determined that adequate safety and tolerability after each panel completion has been demonstrated to permit proceeding to the next panel. In addition, a preliminary assessment of the drug interaction potential of PBTZ169 will be done by the measurement of inhibition or induction of human cytochromes through the metabolism of microdoses of standard probe substrates

Conditions

• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	PBTZ169	PBTZ169 crystalline supplied as powder for oral solution
DRUG	Placebo	matching placebo supplied as powder for oral solution

Timeline

• Start date: 2019-02-21
• Primary completion: 2020-03-20
• Completion: 2020-03-20
• First posted: 2018-12-14
• Last updated: 2020-10-22

Locations

1 site across 1 country: Switzerland