Type 2 Diabetes MellitusPhase 1NCT01131091
A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
A Phase 1 study testing SK-0403 in people with Type 2 Diabetes Mellitus, run by Kowa Research Institute, Inc. at 2 sites in United States.
Trial summary
This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.) Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- SK-0403
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Nov 2010
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is an adult male or female aged 18 to 79 years, inclusive.
- All female subjects (that are not 2 years postmenopausal with a documented serum follicle stimulating hormone level >35 mIU/mL) must have a negative serum pregnancy test at Screening and upon Check in to the study clinic.
- Subject provides written informed consent before any study-specific evaluation is performed.
- Subject is able and willing to comply with the protocol and study procedures.
Who cannot join
- Subject has a BMI >37 kg/m2.
- Subject has taken any prescribed systemic or topical medication
- Subject has donated more than 450 mL of blood within 30 days before the start of dosing.
- Subject has received an investigational drug within 30 days before dosing.
- Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption.
- Subject has had a clinically significant illness
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Minneapolis, Minnesota
Study site
Orlando, Florida
About this study
Official title: A Phase 1, Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)
Read the detailed description
This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each) as follows:
Group A: Subjects with ESRD who are receiving hemodialysis treatment
Group B: Subjects with severe renal impairment
Group C: Subjects with moderate renal impairment
Group D: Subjects with mild renal impairment
Group E: Healthy subjects
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- SK-0403
- 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.
SK-0403Drug
SK-0403 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Subjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment Receives: Drug: SK-0403 |
| Group B | Other | Subjects with severe renal impairment Receives: Drug: SK-0403 |
| Group C | Other | Subjects with moderate renal impairment Receives: Drug: SK-0403 |
| Group D | Other | Subjects with mild renal impairment Receives: Drug: SK-0403 |
| Group E | Other | Healthy subjects Receives: Drug: SK-0403 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403.
Measured: 72 Hours
Secondary outcomes (1)
The secondary objective is to determine the safety and tolerability of a single 400 mg dose of SK 0403 in subjects with renal insufficiency.
Measured: 72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131091
- Sponsor's protocol ID
- SK-0403-1.02US
- Status last verified
- Feb 2011
- First submitted
- 25 May 2010
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
- ClinicalTrials.gov ID
- NCT01131091
- Acronym / sponsor ID
- SK-0403-1.02US
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 May 2010 (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.
This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)
Detailed description
This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each) as follows:
Group A: Subjects with ESRD who are receiving hemodialysis treatment
Group B: Subjects with severe renal impairment
Group C: Subjects with moderate renal impairment
Group D: Subjects with mild renal impairment
Group E: Healthy subjects
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: SK-0403Subjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment |
| Group B | Other | Drug: SK-0403Subjects with severe renal impairment |
| Group C | Other | Drug: SK-0403Subjects with moderate renal impairment |
| Group D | Other | Drug: SK-0403Subjects with mild renal impairment |
| Group E | Other | Drug: SK-0403Healthy subjects |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is an adult male or female aged 18 to 79 years, inclusive.
- All female subjects (that are not 2 years postmenopausal with a documented serum follicle stimulating hormone level >35 mIU/mL) must have a negative serum pregnancy test at Screening and upon Check in to the study clinic.
- Subject provides written informed consent before any study-specific evaluation is performed.
- Subject is able and willing to comply with the protocol and study procedures.
Key exclusion criteria (6 listed)
- Subject has a BMI >37 kg/m2.
- Subject has taken any prescribed systemic or topical medication
- Subject has donated more than 450 mL of blood within 30 days before the start of dosing.
- Subject has received an investigational drug within 30 days before dosing.
- Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption.
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 |
|---|---|---|
| SK-0403SK-0403 400 mg | Drug | Group A, Group B, Group C, Group D, Group E |
Primary outcome
The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403.
Time frame: 72 Hours
1 secondary outcome
The secondary objective is to determine the safety and tolerability of a single 400 mg dose of SK 0403 in subjects with renal insufficiency.
Time frame: 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 10 Feb 2011.
Related trials for Type 2 Diabetes Mellitus
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SK-0403 in people with Type 2 Diabetes Mellitus, run by Kowa Research Institute, Inc. at 2 sites 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 4 inclusion and 6 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 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403. (time frame: 72 Hours). 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 10 Feb 2011.