A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, PK and PD of DA-1241 in healthy male subjects and subjects with T2DM

Key facts

Study ID

NCT03646721

Run by

Dong-A ST Co., Ltd.

People needed

108

Starts

2018-08-29

Expected to finish

2020-05-07

Last updated by the study team

2021-02-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male subjects
• Age ≥ 18 to ≤ 70 years of age.
• Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg/m2.
• Non-diabetic, fasting plasma glucose (FPG) of < 100 mg/dL (measured with YSI at site; one repeat test is allowed)
• HbA1c < 5.7 %
• Non-smoker smoker, defined as: Non-smoker for >12 months (ie, subject has not smoked or used any tobacco product for the 12 months prior to the start of the study) confirmed by a negative nicotine/cotinine test.
• Male subjects must be surgically sterile, or engaged with partners of non-childbearing potential, or if engaged with partners of childbearing potential, the subject and his partner must be willing to use contraceptive methods until 3 months after the last day of IP administration. Males must not donate sperms during the study and until 3 months after the last day of IP administration.
• Upon review, agree to participate and sign informed consent

You may not qualify if…

• Resting blood pressure (BP) > 140/90 mmHg or < 90/60 mmHg. Subjects BP may be re-checked.
• Participation in an investigational drug/device study within 30 days or 5 half-lives within the last dose of any study drug, whichever is longer.
• History of any serious adverse reaction or hypersensitivity to any of the investigational product components or medicinal products with similar chemical structure.
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease that, according to the investigator, would unduly risk the subject's safety or may impact the conduct of the study.
• History of or acute significant gastrointestinal disorder (eg, peptic ulcers, severe GERD), gastric surgery, including surgical treatment for obesity (eg, bariatric surgery, gastric banding), gastric bypass or antrectomy or small bowel resection >20cm or any disorder that would interfere with the swallowing, absorption, distribution, metabolism and excretion of the investigational product. Surgery for appendicitis is acceptable.
• Subject shows evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases (including anti-depressant /anti-anxiety medication),
• Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results, or may present a safety issue to that particular subject. (Laboratory results may be re-checked once on a separate day per Investigator discretion)
• Long QT syndrome or family history of long QT syndrome or corrected QT interval (QTcF) > 450 ms at screening.
• Liver function test results of AST and/or ALT ≥ 1.5 upper limit of normal (ULN).
• Subject had a history of vaso-vagal syncope within 5 years.
• History of any major surgery within 6 months.
• History of any active infection, other than mild viral illness within 30 days prior to dosing.
• Known history or positive test of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) antibody.
• Subjects with a positive urine nicotine/cotinine dipstick test.
• History of alcohol abuse as judged by the Investigator within approximately 1 year. Average weekly alcohol intake > 21 units/week or are unwilling to stop alcohol consumption from 24 hours prior to each dosing until discharged from the clinical research unit (CRU). Positive alcohol test at Screening. (One unit of alcohol equals about 250 mL of beer or lager, 100 mL of wine, or 35 mL of spirits).
• History of illicit drug abuse, within approximately 1 year or evidence of current use as judged by the Investigator. Positive drug test, including marijuana, at Screening.
• Donation or loss of > 500 mL of blood within 56 days.
• Chronic use of over-the-counter or prescription medication within 7 or 14 days prior to dosing per Investigator's discretion (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
• Unable to comply with the safety monitoring requirements of this clinical study or is considered by the investigator to be an unsuitable candidate for the study.
• <Part 2>
• Inclusion Criteria:
• Male and female subjects with T2DM > 6 months.
• Age ≥ 18 to ≤ 70 years of age.
• Body mass index (BMI) ≤ 35 kg/m2.
• On stable therapy with metformin monotherapy or metformin in combination with other oral antidiabetic drugs (OADs) ≥ 1 month. (OADs except metformin will be washed-out prior to the first dosing)

Where it is running

• Clinical Site — Chula Vista, California, United States
• Clinical Pharmacology of Miami — Miami, Florida, United States
• High Point Clinical Trials Center — High Point, North Carolina, United States
• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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