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Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169

NCT04150224 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-02-28

Study results available
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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

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • Nearmedic Plus LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2018-11-23
Completion
2019-02-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04150224 on ClinicalTrials.gov