Diabetes Mellitus, Type 2Phase 1NCT03061981
A Study To Evaluate The Safety,Tolerability, PK and PD Of DA-1241 In Healthy Male Subjects
A Phase 1 study testing Metformin and DA-1241 in people with Diabetes Mellitus, Type 2, run by Dong-A ST Co., Ltd. at 1 site in United States.
Trial summary
This is a randomized, double blind, placebo controlled, single ascending dose study to assess the safety, tolerability, PK, PD and IE with metformin following a single oral dose of DA-1241 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Metformin and DA-1241
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2017to 11 Oct 2017
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent before any of the screening procedures are performed.
- Male subjects aged between 18 and 55 years (both inclusive) at screening.
- Body mass index (BMI) of 18.5 to 32.0 kg/m2 (both inclusive) at screening.
- Medical history, vital signs, physical examination, standard 12-lead ECGs and laboratory investigations (clinical chemistry, hematology and urinalysis) must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the PI considers the deviation to be irrelevant for the purpose of the study. These assessments may be repeated once at the discretion of the PI.
- Subjects with partners of childbearing potential must be willing to use medically acceptable double barrier forms of contraception from IMP administration until at least 3 months after the last day of IMP administration. Subjects must not donate sperm for the duration of the study and for at least 3 months after the last day of IMP administration.
- Is a non-smoker or non-tobacco/nicotine user confirmed with urine cotinine test at screening and on admission to the EPCU. Nicotine products include, but are not limited to, tobacco cigarettes, electronic cigarettes, snuff, cigars, and pipes, including hookah or water pipes. The use of nicotine patches or gum (e.g., products used as part of a smoking cessation program) is not allowed.
Who cannot join
- Has a known hypersensitivity to any component of the formulation of DA- 1241 or any of the excipients or to medicinal products with similar chemical structures.
- Has a history or presence of any clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal or endocrine disease or other abnormality that may impact the ability of the subject to participate or potentially confound the study results.
- Has a glycated hemoglobin A1C (HgbA1C) of ≥ 6.5% consistent with possible diabetes at screening.
- Any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
- Any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study.
- Subject has a history of drinking > 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) within 3 months prior to admission to the EPCU.
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- Have positive test results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (anti HCV) or human immunodeficiency virus 1 and/or -2 antibodies (anti HIV-1 and/or -2) at screening.
- History of drug abuse or has a positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) at screening or on Day 1.
- Has donated or lost 450 mL or more of his blood volume (including plasmaphoresis), or had a transfusion of any blood product within 3 months before screening.
- Taking any medication including prescription, herbal remedies, vitamin supplements, dietary supplements or other over-the-counter (OTC) products within 14 days or 5 half-lives of the product (whichever period is longer) before admission to the EPCU.
- Has an abnormal (clinically significant) ECG at screening or on Day 1. Entry of any subject with an abnormal (but not clinically significant) ECG must be approved and documented by signature, by the PI or medically qualified Sub-investigator.
- Has a supine blood pressure (BP) outside the ranges of 90 to 140 mmHg, inclusive, for systolic BP and 50 to 90 mmHg, inclusive, for diastolic BP, or has a resting heart rate outside the range of 45 to 100 beats per minute (bpm). If any of the values are out of range, the assessment may be repeated once for eligibility determination, at screening and admission on Day 1.
- Has a corrected QT interval using Fridericia's corrected formula (QTcF) interval greater than 450 msec or PR interval outside the range of 120 to 220 msec. If any values are out of range, the ECG may be repeated once for eligibility determination, at screening and admission on Day 1.
- Has an abnormal laboratory value that suggests a clinically significant underlying disease or has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values greater than 1.5 times the upper limit of normal (ULN). Laboratory assessments may be repeated once to confirm eligibility at screening and on Day 1.
- Participation in another study with an experimental drug within 30 days or 5 half-lives, whichever is longer, of this study's screening visit. Participation is defined as the date of last dose received in the previous study.
- Unwilling to abstain from vigorous exercise within 48 hours before Day 1.
- Intake of any food or drinks containing grapefruit, Chinese grapefruit (pomelo), star fruit, pomegranate or Seville orange (including marmalade) within 48 hours before admission to the EPCU.
- Have used alcohol within 72 hours prior to screening or within 72 hours prior to admission to the EPCU.
- Is unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
- Is a study-site employee or an immediate family member or dependent (e.g., spouse, parent, child or sibling) of a study-site employee who is involved in the conduct of this study.
- Has difficulty swallowing 2 tablets at the same time.
Trial locations and contacts
1 site in 1 country.
United States1 site
Early Phase Clinical Unit
Baltimore, Maryland, 21225
About this study
Official title: A Phase I, First In Human, Double Blind, Placebo Controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Interaction Effect With Metformin Following A Single Oral Dose Of DA-1241 In Healthy Male Subjects
This is a randomized, double blind, placebo controlled, single ascending dose study to assess the safety, tolerability, PK, PD and IE with metformin following a single oral dose of DA-1241 in healthy male subjects.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo, Metformin, DA-1241
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
After pre-dose assessments on Day 1, subjects will receive a single oral dose of IMP after an overnight fast in each Treatment Period.
MetforminDrug
Subjects in the IE cohort will receive 500 mg metformin (IR formulation) at 12 hours on Day 1 and a single oral dose of the IMP with 500 mg metformin (IR formulation) after an overnight fast on Day 1, in Treatment Period 2.
DA-1241Drug
After pre-dose assessments on Day 1, subjects will receive a single oral dose of IMP after an overnight fast in each Treatment Period .
| Study group | Role | What they receive |
|---|---|---|
| DA-1241:8 subjects in each cohort(Cohort 1-6) | Active comparator | Subjects will participate in 1 of 6 cohorts consisting of 10 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 8:2 (DA-1241 to matching placebo). Receives: Drug: DA-1241 |
| Placebo: 2 subjects in each cohort(Cohort 1-6) | Placebo comparator | Subjects will participate in 1 of 6 cohorts consisting of 10 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 8:2 (DA-1241 to matching placebo). Receives: Drug: Placebo |
| DA-1241 in IE Cohort: 8 subjects in choosen cohort | Other | One of the cohorts will be selected,based on a review of the data from cohort 1-6, to assess the IE of metformin on the PK of DA-1241. Receives: Drug: Metformin; Drug: DA-1241 |
| Placebo in IE Cohort: 2 subjects in choosen cohort | Other | One of the cohorts will be selected,based on a review of the data from cohort 1-6, to assess the IE of metformin on the PK of DA-1241. Receives: Drug: Placebo; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Safety and Tolerability] 12-lead ECGs, Vital signs. Physical examinations, Clinical laboratory testing and Adverse event assessments
Measured: Through study completion, an average of 40 days for each treatment period
Secondary outcomes (11)
Maximum concentration of DA-1241 (Cmax)
Measured: Through the treatment period; 72 hours
Time of maximum plasma DA-1241 concentration (Tmax)
Measured: Through the treatment period; 72 hours
Area under the concentration-time curve (AUC)
Measured: Through the treatment period; 72 hours
Apparent terminal elimination half-life (t½)
Measured: Through the treatment period; 72 hours
Apparent total systemic clearance after oral administration (CL/F)
Measured: Through the treatment period; 72 hours
Apparent volume of distribution (Vz/F)
Measured: Through the treatment period; 72 hours
Amount of DA-1241 excreted unchanged in the urine in each collection interval(Ae)
Measured: Through the treatment period; 72 hours
Cumulative amount of DA-1241 excreted unchanged in the urine (Cum Ae)
Measured: Through the treatment period; 72 hours
Percentage fraction of DA-1241 excreted unchanged in the urine in each collection interval(Fe)
Measured: Through the treatment period; 72 hours
Cumulative percentage fraction of DA-1241 excreted unchanged in the urine (Cum Fe)
Measured: Through the treatment period; 72 hours
Renal clearance (CLR)
Measured: Through the treatment period; 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start29 Mar 2017
- Primary completion11 Oct 2017
- Study completion11 Oct 2017
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061981
- Sponsor's protocol ID
- DA1241_DM_Ia
- Status last verified
- Nov 2017
- First submitted
- 9 Feb 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First In Human, Double Blind, Placebo Controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Interaction Effect With Metformin Following A Single Oral Dose Of DA-1241 In Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03061981
- Acronym / sponsor ID
- DA1241_DM_Ia
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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.
This is a randomized, double blind, placebo controlled, single ascending dose study to assess the safety, tolerability, PK, PD and IE with metformin following a single oral dose of DA-1241 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DA-1241:8 subjects in each cohort(Cohort 1-6) | Active comparator | Drug: DA-1241Subjects will participate in 1 of 6 cohorts consisting of 10 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 8:2 (DA-1241 to matching placebo). |
| Placebo: 2 subjects in each cohort(Cohort 1-6) | Placebo comparator | Drug: PlaceboSubjects will participate in 1 of 6 cohorts consisting of 10 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 8:2 (DA-1241 to matching placebo). |
| DA-1241 in IE Cohort: 8 subjects in choosen cohort | Other | Drug: Metformin, Drug: DA-1241One of the cohorts will be selected,based on a review of the data from cohort 1-6, to assess the IE of metformin on the PK of DA-1241. |
| Placebo in IE Cohort: 2 subjects in choosen cohort | Other | Drug: Placebo, Drug: MetforminOne of the cohorts will be selected,based on a review of the data from cohort 1-6, to assess the IE of metformin on the PK of DA-1241. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent before any of the screening procedures are performed.
- Male subjects aged between 18 and 55 years (both inclusive) at screening.
- Body mass index (BMI) of 18.5 to 32.0 kg/m2 (both inclusive) at screening.
- Medical history, vital signs, physical examination, standard 12-lead ECGs and laboratory investigations (clinical chemistry, hematology and urinalysis) must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the PI considers the deviation to be irrelevant for the purpose of the study. These assessments may be repeated once at the discretion of the PI.
- Subjects with partners of childbearing potential must be willing to use medically acceptable double barrier forms of contraception from IMP administration until at least 3 months after the last day of IMP administration. Subjects must not donate sperm for the duration of the study and for at least 3 months after the last day of IMP administration.
Key exclusion criteria (21 listed)
- Has a known hypersensitivity to any component of the formulation of DA- 1241 or any of the excipients or to medicinal products with similar chemical structures.
- Has a history or presence of any clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal or endocrine disease or other abnormality that may impact the ability of the subject to participate or potentially confound the study results.
- Has a glycated hemoglobin A1C (HgbA1C) of ≥ 6.5% consistent with possible diabetes at screening.
- Any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
- Any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study.
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 |
|---|---|---|
| PlaceboAfter pre-dose assessments on Day 1, subjects will receive a single oral dose of IMP after an overnight fast in each Treatment Period. | Drug | Placebo in IE Cohort: 2 subjects in choosen cohort, Placebo: 2 subjects in each cohort(Cohort 1-6) |
| MetforminSubjects in the IE cohort will receive 500 mg metformin (IR formulation) at 12 hours on Day 1 and a single oral dose of the IMP with 500 mg metformin (IR formulation) after an overnight fast on Day 1, in Treatment Period 2. | Drug | DA-1241 in IE Cohort: 8 subjects in choosen cohort, Placebo in IE Cohort: 2 subjects in choosen cohort |
| DA-1241After pre-dose assessments on Day 1, subjects will receive a single oral dose of IMP after an overnight fast in each Treatment Period . | Drug | DA-1241 in IE Cohort: 8 subjects in choosen cohort, DA-1241:8 subjects in each cohort(Cohort 1-6) |
Primary outcome
[Safety and Tolerability] 12-lead ECGs, Vital signs. Physical examinations, Clinical laboratory testing and Adverse event assessments
Time frame: Through study completion, an average of 40 days for each treatment period
11 secondary outcomes
Maximum concentration of DA-1241 (Cmax)
Time frame: Through the treatment period; 72 hours
Time of maximum plasma DA-1241 concentration (Tmax)
Time frame: Through the treatment period; 72 hours
Area under the concentration-time curve (AUC)
Time frame: Through the treatment period; 72 hours
Apparent terminal elimination half-life (t½)
Time frame: Through the treatment period; 72 hours
Apparent total systemic clearance after oral administration (CL/F)
Time frame: Through the treatment period; 72 hours
Apparent volume of distribution (Vz/F)
Time frame: Through the treatment period; 72 hours
Amount of DA-1241 excreted unchanged in the urine in each collection interval(Ae)
Time frame: Through the treatment period; 72 hours
Cumulative amount of DA-1241 excreted unchanged in the urine (Cum Ae)
Time frame: Through the treatment period; 72 hours
Percentage fraction of DA-1241 excreted unchanged in the urine in each collection interval(Fe)
Time frame: Through the treatment period; 72 hours
Cumulative percentage fraction of DA-1241 excreted unchanged in the urine (Cum Fe)
Time frame: Through the treatment period; 72 hours
Renal clearance (CLR)
Time frame: Through the treatment period; 72 hours
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 20 Nov 2017.
- Individual participant dataSharing planned: No
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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 Metformin and DA-1241 in people with Diabetes Mellitus, Type 2, run by Dong-A ST Co., Ltd. at 1 site in United States.
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 6 inclusion and 21 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 20 Nov 2017. 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 United States. 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?
[Safety and Tolerability] 12-lead ECGs, Vital signs. Physical examinations, Clinical laboratory testing and Adverse event assessments (time frame: Through study completion, an average of 40 days for each treatment period). 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 20 Nov 2017.