A Multiple Ascending Dose Phase I Study of DBPR108 in Healthy Male Subjects

NCT02163278 | Completed Phase 1

• 1 other identifier: DBPR108-102
• 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 multiple oral doses of DBPR108 in healthy male subjects.

Conditions

Diabetes Mellitus, Type 2

Keywords

DBPR108; DPP4; Diabetes; Glucagon-like peptide-1 (GLP-1); Incretins

Outcome Measures

Primary Outcomes (1)

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

  Each subject will be followed for the duration of 6 hospital stays, an expected average of 5 weeks

Secondary Outcomes (2)

• Pharmacokinetic parameters

  33 time points during 12 days (including measurements before dosing)

• Pharmacodynamic parameters

  34 time points during 10 days (including measurements before dosing)

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 investigational product intact.
• Aged between 20 and 45 years (inclusive) at the screening visit.
• 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 18.5 kg/m2 or greater than or equal to 24 kg/m2 at the screening visit. Body mass index is determined as total body weight/height2 (kg/m2).
• 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 on Day -1. Normal ECG includes (1) sinus rhythm, (2) pulse rate between 45 and 90 bpm, (3) Corrected QT (QTc) interval equal to or less than 450 ms (corrected cf Bazett 1920), (4) QRS interval less than 110 ms, (5) PR interval less than 200 ms, and (6) morphology consistent with healthy cardiac conduction and function.
• Is not normoglycemic defined as fasting glucose at less than 70 mg/dL (3.9 mmol/L) and greater than 99 mg/dL (5.5 mmol/L), based on the laboratory tests at screening or at admission on Day -1, or has known diabetes or impaired glucose tolerance (Re-testing of fasting glucose on the same sample collected from the subject with initial fasting glucose value of 100-105 mg/dL on Day -1 is acceptable. However, if the re-testing fasting glucose value is still greater than 99 mg/dL, the subject shall be excluded and considered as screen-failure).
• Has a platelet count less than 150,000/μL.
• Uses any antihyperglycemic agents at screening or at admission on Day -1.
• 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 on Day -1.
• Has a clinically significant psychiatric, renal, hepatic, cardiovascular, gastrointestinal, or neurologic disease at screening or at admission on Day -1.
• 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 before Day -1.
• Excessive intake of caffeine-containing drinks or food (i.e., coffee, tea, chocolate, PAOLYTA B Liq, WHISBIH Liq, or cola \[more than 6 units of caffeine per day\]). One caffeine unit is contained in the following items: 1 (177.4 mL) cup of coffee, 2 (354.9 mL) cans of cola, 1 (354.9 mL) cup of tea, ½ (118.3 mL) cup of energy drink (e.g., PAOLYTA B Liq or WHISBIH Liq), or 3 oz of chocolate.
• Use of drugs with cytochrome P450 enzyme-inducing or
• inhibiting properties 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (1)

Taipei Medical University - Taipei Medical University Hospital

Taipei, 11031, 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

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: June 6, 2014
• First Posted: June 13, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 28, 2016

Record last verified: 2015-04

Locations

TW (1)