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Phase 1 Study of PBTZ169

NCT03036163 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-04-13

Study results available
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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

Conditions

Interventions

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

Sponsors & Collaborators

  • OCT LLC

    collaborator INDUSTRY

  • Nearmedic Plus LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-09-30
Completion
2016-11-30

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Entities

Diseases

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 NCT03036163 on ClinicalTrials.gov