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

NCT01650324 | Completed Phase 1 Results

• 1 other identifier: DBPR108-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

DBPR108; DPP4; Diabetes; GLP-1; Incretins

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  There were 4 mild adverse events observed during the course of study.

  Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7.

Secondary Outcomes (4)

• 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

Study Arms (2)

DBPR108

EXPERIMENTAL

Drug: DBPR108

matching placebo

PLACEBO COMPARATOR

Drug: matching placebo

Interventions

DBPR108 DRUG

DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.

DBPR108

matching placebo DRUG

Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.

matching placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (1)

Taipei Medical University - Wanfang Hospital

Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

DBPR108

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Yi-Jen Chen
• Organization: Taipei Medical University - Wanfang Hospital

yjchen@tmu.edu.tw

886-2-2930-7930

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 26, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 28, 2014
• Results First Posted: August 28, 2014

Record last verified: 2014-02

Locations

TW (1)