A Double-blind, Randomized, Placebo-controlled, Dose-ranging, Single-dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DBPR108 in Healthy Male Subjects
A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects
Sponsors
Source
National Health Research Institutes, Taiwan
Oversight Info
Has Dmc
No
Brief 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.
Detailed Description
This study represents the first administration of dipeptidyl peptidase 4 (DPP4) inhibitor
DBPR108 to humans to evaluate the safety, tolerability, and pharmacokinetic (PK) and
pharmacodynamic (PD) properties following single oral doses in healthy subjects.
DPP4 is a validated drug target for the treatment of human type 2 diabetes. Objectives of the
study will be to characterize the safety and tolerability of single doses of DBPR108; to
characterize the single dose PK of DBPR108 in plasma and urine; to characterize the single
dose PD of DBPR108 on glucose, glucagon, dipeptidyl peptidase 4 activity, and total and
active forms of glucagon-like peptide-1 (GLP-1) in plasma levels and insulin and C-peptide in
serum levels.
Overall Status
Completed
Start Date
2012-07-01
Completion Date
2012-12-01
Primary Completion Date
2012-12-01
Phase
Phase 1
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7. |
Secondary Outcome
Measure |
Time Frame |
|
Profile of Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC From 0 to Infinity) |
predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose |
|
Profile of Pharmacokinetics - Observed Maximum Plasma Concentration (Cmax) |
predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose |
|
Profile of Pharmacokinetics - Time of Maximum Plasma Concentration (Tmax) |
predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose |
|
Change of Dipeptidyl Peptidase 4 (DPP4) Activities Between 48 Hrs Post Dose and 0 hr Predose |
predose (0 hr) and 48 hrs post dose |
Enrollment
32
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.
Arm Group Label
DBPR108
Intervention Type
Drug
Intervention Name
Description
Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.
Arm Group Label
matching placebo
Eligibility
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.
Gender
Male
Minimum Age
20 Years
Maximum Age
45 Years
Healthy Volunteers
Accepts Healthy Volunteers
Location
Facility |
|
Taipei Medical University - Wanfang Hospital Taipei 116 Taiwan |
Location Countries
Country
Taiwan
Verification Date
2014-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
DBPR108
Arm Group Type
Experimental
Arm Group Label
matching placebo
Arm Group Type
Placebo Comparator
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Study First Submitted
July 19, 2012
Study First Submitted Qc
July 23, 2012
Study First Posted
July 26, 2012
Last Update Submitted
August 15, 2014
Last Update Submitted Qc
August 15, 2014
Last Update Posted
August 28, 2014
Results First Submitted
May 20, 2014
Results First Submitted Qc
August 15, 2014
Results First Posted
August 28, 2014
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.