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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect of KQ-791

NCT02370043 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-11-26

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability, and the effect of food on KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different dose levels) and 1 placebo dose over the course of the study. Up to 6 escalating dose levels may be studied, in two distinct groups or cohorts.

Conditions

Interventions

DRUG

KQ-791

Capsules administered orally while fasting, in up to 3 periods

DRUG

KQ-791 (after meal)

Single dose of KQ-791 in capsules, after a meal, in 1 period

DRUG

Placebo

Capsules, administered orally, in 1 period

Sponsors & Collaborators

  • Kaneq Bioscience Limited

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Canada

Study Locations

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Entities

Drugs
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 NCT02370043 on ClinicalTrials.gov