Multiple Ascending Dose Study of GMC-252-L-Lys Salt in Healthy Subjects and Type 2 Diabetics

NCT02744820 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-10-12

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of GMC-252-L-Lysine salt (GMC-252) in healthy subjects and type 2 diabetics.

The secondary objective is to explore the effect of multiple oral doses of GMC-252 on pharmacodynamic(PD) parameters in type 2 diabetics.

Conditions

Interventions

DRUG

GMC-252-L-Lysine Salt

1 dose by oral route, once a day, 28 days

OTHER

Placebo

Matching doses by oral route, once a day, 28 days

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY
  • Genmedica Therapeutics S.L.

    lead INDUSTRY

Principal Investigators

  • Robert Adams, MBBS · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02744820 on ClinicalTrials.gov