Overview

A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
Male
Summary
The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of single oral doses of DBPR108 in healthy male subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Criteria
Inclusion Criteria:

- Male with suitable veins for cannulation or repeated venipuncture, and must be able to
swallow the study drug intact;

- Aged between 20 and 45 years (inclusive) at the screening visit; and

- Able to provide written informed consent and willing to comply with the study protocol
procedures and restrictions.

Exclusion Criteria:

- Has a body weight less than 50 kg and/or body mass index (BMI) less than 18 kg/m2 or
greater than 30 kg/m2 at the screening visit;

- Has a creatinine clearance (Ccr) less than 80 mL/min at screening;

- Is not in good general health as judged by the Investigator based on routine medical
history, vital signs, physical examination, ECG, laboratory tests, and urinalysis at
the screening visit or at admission for the residential period;

- Is not normoglycemic defined as fasting glucose at less than 70 mg/dL (3.9 mmol/L) and
greater than 100 mg/dL (5.5 mmol/L);

- Has a platelet count less than 150,000/µL;

- Uses any antihyperglycemic agents at screening or at admission for the residential
period;

- Has a history or presence of any disease or condition known to interfere with the
absorption, distribution, metabolism, or excretion of drugs at the screening visit or
at admission for the residential period;

- Has a clinically significant psychiatric, renal, hepatic, cardiovascular,
gastrointestinal, or neurologic disease at screening or at admission for the
residential period;

- Is a smoker and/or has used nicotine-containing products within the last 6 months
prior to the screening for the current study and/or has a history of alcohol abuse;

- Has donated blood or participated in another clinical study within 8 weeks preceding
the day of admission;

- Excessive intake of caffeine-containing drinks or food (ie, coffee, tea, chocolate,
PAOLYTA B Liq, WHISBIH Liq, or cola [more than 6 units of caffeine per day]);

- Use of drugs with enzyme-inducing properties such as St. John's Wort within 4 weeks
prior to the first administration of investigational product;

- Has used prescription or nonprescription medication (except for occasional use of
paracetamol or nasal spray) or herbal remedies or vitamins or minerals within 2 weeks
or 5 half-lives of the drug, whichever is longer, prior to dosing until end of study;

- Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade,
or other products containing grapefruit or Seville oranges within 7 days of the first
administration of investigational product;

- Male subjects who are unwilling to use barrier contraception in addition to having
their partner use another method of contraception, for the duration of the study and
for 3 months after dosing;

- Has a positive result on screening for serum hepatitis B surface antigen (HBsAg),
hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV);

- Has received a blood transfusion and/or has HCV infection;

- Positive result on screening for drugs of abuse, alcohol, or cotinine (nicotine) at
screening or admission; or

- Involved in the planning or conduct of the study.