Healthy adult subjects
Conditions
Interventions
investigational material(s)
Generic name etc : GT-02037
INN of investigational material : -
Therapeutic category code : 249 Other hormone preparations (including antihormone preparations)
Dosage and A
Sponsors
GlyTech, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese adult male (2) 20 to 40 years old at the time of consent (3) Body weight: over 50 kg (4) Body Mass Index: between 18.5 and 25.0 at the screening examination (5) Provided written informed consent
Exclusion criteria
Exclusion criteria: (1) Those who have prior medical history of central nervous system, circulatory system, respiratory system, blood / hematopoietic system, gastrointestinal system, hepatic / renal function, etc. conditions that are considered inappropriate for this study (2) Hypersensitivity or idiosyncratic reaction to any drug (3) Those having a food allergy or allergic disease considered inappropriate for this study (4) Those who are susceptible to hypersensitivity rash symptoms (erythema, wheal, etc.) (5) Alcohol or drug dependence (6) Those having immunological test result abnormalities (HBs antigen, HCV antibody, syphilis test (RPR method, TP antibody), HIV antigen / antibody) (7) Those who have a positive result in the urine drug screening test (8) Those who have consumed foods / supplements containing alcohol, grapefruit (fruit / pulp), or St. John's wort within one week prior to investigational drug administration (9) Those who have experienced muscle pain due to intense exercise or sunburn within one week prior to investigational drug administration (10) Those administrated of any investigational drug within two weeks before this study (11) Those who have participated in other clinical trials or studies and received the drug within 16 weeks before this study (in the case of other clinical bioequivalence studies, within 12 weeks) (12) Those who have given 400mL or more of whole blood within 12 weeks, 200mL or more within 4 weeks, or blood components within 2 weeks before this study (13) Those who cannot practice contraception from the administration of the investigational drug to post-test (or follow-up) (14) Those previously administrated GT-02037 or somatostatin analog drug (15) Those with clinically significant abnormalities in laboratory tests, vital signs, 12-lead ECG tests, or medical examinations at the time of subject screening (16)Those who are judged by the clinical investigator or sub-investigators to be inappropriate for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety AEs, Clinical examination, Injection site reaction, Vital signs, 12-lead ECGs, Laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics pharmacodynamics Secondary endopoint: Pharmacokinetics(Plasma GT-02037 concentrations, urinary GT-02037 excretions, PK parameters) Exploratory endopoint: Pharmacodynamics(Insulin, Glucagon, HbA1c, IGF-1) | — |
Countries
Japan
Outcome results
None listed