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

Phase 1

Terminated

• Conditions: Type 2 Diabetes Mellitus; Healthy
• Interventions: Drug: GMC-252-L-Lysine Salt; Other: Placebo

• Registration Number: NCT02744820
• Lead Sponsor: Genmedica Therapeutics S.L.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2 (Part 1)	GMC-252-L-Lysine Salt	Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Cohort 2 (Part 1)	Placebo	Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Cohort 1 (Part 1)	GMC-252-L-Lysine Salt	Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Cohort 1 (Part 1)	Placebo	Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Cohort 3 (Part 1)	GMC-252-L-Lysine Salt	Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Cohort 4 (Part 2)	GMC-252-L-Lysine Salt	Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Cohort 4 (Part 2)	Placebo	Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo
Cohort 3 (Part 1)	Placebo	Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants with Serious and Non-Serious Adverse Events	28 days plus 14 days post last dose	Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Simbec Research Ltd; 🇬🇧 Merthyr Tydfil, United Kingdom

BioKinetic Europe Ltd.; 🇬🇧 Belfast, United Kingdom