Diabetes Mellitus, Type 2Phase 1NCT01650324
A Single-dose Phase 1 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 single 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
- Jul 2012to Dec 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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.
Who cannot join
- 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;
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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 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging, Single-dose Study of the Safety, 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 single oral doses of DBPR108 in healthy male subjects.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- DBPR108, matching placebo
- Keywords
- DBPR108, DPP4, Diabetes, 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
There were 4 mild adverse events observed during the course of study.
Measured: 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)
Plasma samples were used to determine the AUC from time 0 to infinity for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.
Measured: 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)
Plasma samples were used to determine the Cmax for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.
Measured: 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)
Plasma samples were used to determine the Time of Maximum Plasma Concentration for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.
Measured: 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
Change of plasma DPP4 activity at 48 hrs post dose from predose (0 hr). The values were computed as areas under the DPP4 activity-time curve using ANCOVA model, in which the unit of the activity is pmol/min.
Measured: predose (0 hr) and 48 hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- NCT01650324
- Sponsor's protocol ID
- DBPR108-101
- Status last verified
- Feb 2014
- First submitted
- 19 Jul 2012
- Last updated
- 28 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Dose-ranging, Single-dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DBPR108 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01650324
- Acronym / sponsor ID
- DBPR108-101
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- DBPR108, DPP4, Diabetes, 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
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Posted 28 Aug 2014
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 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.
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 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.
Key exclusion criteria (19 listed)
- 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;
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: Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7.
There were 4 mild adverse events observed during the course of study.
4 secondary outcomes
Profile of Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC From 0 to Infinity)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: predose (0 hr) and 48 hrs post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 19 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 Aug 2014. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7.). 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 Aug 2014.