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
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
- Healthy
- Type 2 Diabetes Mellitus
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
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