NCT04150224

Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169

An Open-label, Prospective Study of Safety, Tolerability, Pharmacokinetics and Food Effects of PBTZ169, 80 mg Capsules, When Used in Ascending Doses in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nearmedic Plus LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers

Detailed description

Open-label prospective non-comparativerandomized cohort study of safety, tolerability, pharmacokinetics and the effect of food of PBTZ169 in adult healthy volunteers after single and multiple oral administration. Study was conducted in one study center in the Russian Federation. The study included two stages: Stage 1 - single or double oral administration with dose escalation (fasted/after meal) in 5 cohorts 10 healthy volunteers each plus 5 back-up volunteers; Stage 2 - multiple oral administration once a day after meal for 14 days in 1 cohort of 10 healthy volunteers.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	PBTZ169 640 mg OD	Two administrations once a day with a wash-out period: food effect
DRUG	PBTZ169 640 mg BiD	Twice a day fasted; 1 day of administration
DRUG	PBTZ169 960 mg SD	Once a day fasted
DRUG	PBTZ169 1280 mg SD	Once a day fasted
DRUG	PBTZ169 1280 mg MD	Once a day after meal, 14 doses

Timeline

• Start date: 2018-07-03
• Primary completion: 2018-11-23
• Completion: 2019-02-01
• First posted: 2019-11-04
• Last updated: 2020-02-28
• Results posted: 2020-02-28

Locations

1 site across 1 country: Russia