Diabetes Mellitus, Type 2Phase 1NCT02163278
A Multiple Ascending Dose Phase I Study of DBPR108 in Healthy Male Subjects
A Phase 1 study testing DBPR108 in people with Diabetes Mellitus, Type 2, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- DBPR108
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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 on Day -1.
- Involved in the planning or conduct of the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University - Taipei Medical University Hospital
Taipei, 11031
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DBPR108 in Healthy Male Subjects
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.
Read the detailed description
This study represents the administration of dipeptidyl peptidase 4 (DPP4) inhibitor DBPR108 to humans to evaluate the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties following multiple 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 assess the safety and tolerability, PKs and PDs of DBPR108 at steady state after administration of multiple oral doses to healthy male subjects.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- DBPR108, matching placebo
- Keywords
- DBPR108, DPP4, Diabetes, Glucagon-like peptide-1 (GLP-1), Incretins
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBPR108Drug
DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.
matching placeboDrug
Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.
| Study group | Role | What they receive |
|---|---|---|
| DBPR108 | Experimental | Not described Receives: Drug: DBPR108 |
| matching placebo | Placebo comparator | Not described Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: Each subject will be followed for the duration of 6 hospital stays, an expected average of 5 weeks
Secondary outcomes (2)
Pharmacokinetic parameters
PK parameters are including: Cmax, Cmin, Cavg, Cmin,i , Tmax, Tlast, t1/2, AUCτ, AUC0-t, AUC0-inf, % Fluctuation, Apparent body clearance following extravascular dosing (CL/F), Vz/F, Aet1-t2, Ae0-t, fe0-t, Renal clearance (CLR), Accumulation index (AI) and Accumulation ration (AR)
Measured: 33 time points during 12 days (including measurements before dosing)
Pharmacodynamic parameters
PD parameters are including: Emax, Emin, Time to maximum effect (TEmax), TEmin, Area under the response versus time curve during a dosing interval ( AUECτ) and Area under the response versus time curve from time zero to the time of last quantifiable response (AUEC0-t)
Measured: 34 time points during 10 days (including measurements before dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163278
- Sponsor's protocol ID
- DBPR108-102
- Status last verified
- Apr 2015
- First submitted
- 6 Jun 2014
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DBPR108 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02163278
- Acronym / sponsor ID
- DBPR108-102
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- DBPR108, DPP4, Diabetes, Glucagon-like peptide-1 (GLP-1), Incretins
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study represents the administration of dipeptidyl peptidase 4 (DPP4) inhibitor DBPR108 to humans to evaluate the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties following multiple 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 assess the safety and tolerability, PKs and PDs of DBPR108 at steady state after administration of multiple oral doses to healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBPR108 | Experimental | Drug: DBPR108 |
| matching placebo | Placebo comparator | Drug: matching placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBPR108DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg. | Drug | DBPR108 |
| matching placeboMatching placebo capsules in four doses beginning at 25 mg and rising to 600 mg. | Drug | matching placebo |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Each subject will be followed for the duration of 6 hospital stays, an expected average of 5 weeks
2 secondary outcomes
Pharmacokinetic parameters
Time frame: 33 time points during 12 days (including measurements before dosing)
Pharmacodynamic parameters
Time frame: 34 time points during 10 days (including measurements before dosing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DBPR108 in people with Diabetes Mellitus, Type 2, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: Each subject will be followed for the duration of 6 hospital stays, an expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.