A Double Blind, Placebo-controlled, Randomised, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GMC-252 in Healthy Male Subjects and Male Type 2 Diabetics
Overview
- Phase
- Phase 1
- Intervention
- GMC-252-L-Lysine Salt
- Conditions
- Healthy
- Sponsor
- Genmedica Therapeutics S.L.
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Number of Participants with Serious and Non-Serious Adverse Events
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 3 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Intervention: GMC-252-L-Lysine Salt
Cohort 1 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Intervention: GMC-252-L-Lysine Salt
Cohort 1 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Intervention: Placebo
Cohort 2 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Intervention: GMC-252-L-Lysine Salt
Cohort 2 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Intervention: Placebo
Cohort 3 (Part 1)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Intervention: Placebo
Cohort 4 (Part 2)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Intervention: GMC-252-L-Lysine Salt
Cohort 4 (Part 2)
Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: 28 days plus 14 days post last dose
Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)
Secondary Outcomes
- Area Under the Concentration-Time Curve(28 days plus 14 days post last dose)
- Maximal Concentration (Cmax)(28 days plus 14 days post last dose)
- Time to reach steady state(28 days plus 14 days post last dose)