NCT03036163

Phase 1 Study of PBTZ169

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Nearmedic Plus LLC · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in adult man healthy volunteers after single and multiple oral fasting administration. Study was conducted in one study center in Russian Federation. The study included two stages: * Stage 1 - single oral fasting administration with dose escalation in 5 cohorts 6 healthy man volunteers each in main groups (plus 1 back-up volunteer in every group); * Stage 2 - multiple oral fasting administration with dose escalation in 2 cohorts 6 healthy man volunteers each in main groups (plus 1 back-up volunteer in every group). Screening procedures for each cohort performed within 7 days before the drug prescription and after the end of administration period in previous cohort. Screening in cohorts 2 and 6 was started only after safety tolerability and PK data analysis of previous cohorts. All volunteers met the study inclusion/exclusion criteria was included successively into the following cohorts on Stage 1 (actual data): * Cohort 1 (C1) - 6 volunteers of the main group each of whom received once single dose of the drug - 1 capsule containing 40 mg of PBTZ169; * Cohort 2 (C2) - 6 volunteers of the main group each of whom received once 80 mg of PBTZ169 (2 capsules 40 mg); * Cohort 3 (C3) - 6 volunteers of the main group each of whom received once 160 mg of PBTZ169 (4 capsules 40 mg); * Cohort 4 (C4) - 6 volunteers of the main group each of whom received once 320 mg of PBTZ169 (8 capsules 40 mg); * Cohort 5 (C5) - 6 volunteers of the main group each of whom received once 640 mg of PBTZ169 (16 capsules 40 mg). On Stage 2 (actual data): * Cohort 6 (C6) - 5 volunteers of the main group each of whom received 320 mg of PBTZ169 (8 capsules 40 mg) once daily for 14 days; * Cohort 7 (C7) - 5 volunteers of the main group each of whom received 640 mg of PBTZ169 (16 capsules 40 mg) once daily for 14 days. Safety was assessed throughout the study. For every volunteer series of urine and venous blood samples was collected for the safety, tolerability and PK assessment of PBTZ169.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	PBTZ169 - 40 mg	40 mg of PBTZ169 (1 capsule) orally once in fasting state
DRUG	PBTZ169 - 80 mg	80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
DRUG	PBTZ169 - 160 mg	160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
DRUG	PBTZ169 - 320 mg	320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
DRUG	PBTZ169 - 640 mg	640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
DRUG	PBTZ169 - 320 mg (multiple administration)	320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
DRUG	PBTZ169 - 640 mg (multiple administration)	640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-09-01
• Completion: 2016-11-01
• First posted: 2017-01-30
• Last updated: 2020-04-13
• Results posted: 2020-04-13