Type 2 DiabetesPhase 1NCT02817217
The DDI Study of SP2086 and Valsartan
A Phase 1 study testing SP2086 and Valsartan in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SP2086 and Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Jul 2016
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2.
Who cannot join
- History of diabetes
- History of heart failure or renal insufficiency
- Urinary tract infections, or vulvovaginal mycotic infections
- History of or current clinically significant medical illness as determined by the Investigator
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
- Known allergy to SP2086 or Valsartan or any of the excipients of the formulation of SP2086 or Valsartan
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
People's Liberation Army General Hospital of Chengdu Military Region
Chengdu, Sichuan
Xiaolan Yong, docter, 028-86571275, Yongxiaolan@126.com
About this study
Official title: The Drug Interaction Study of SP2086 and Valsartan in Healthy Subjects
The purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers.
- Conditions
- Type 2 Diabetes
- Being tested
- SP2086, Valsartan
- 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.
SP2086Drug
SP2086 will be administered orally (by mouth) as 100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.
ValsartanDrug
SP2086 will be administered orally (by mouth) as100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.
| Study group | Role | What they receive |
|---|---|---|
| SP2086 and Valsartan | Other | Not described Receives: Drug: SP2086; Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax) of SP2086
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Valsartan
Measured: up to Day 9
The maximum plasma concentration (Cmax) of SP2086 acid
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Valsartan
Measured: up to Day 9
The maximum plasma concentration (Cmax) of Valsartan
Cmax (a measure of the body's exposure to Valsartan) will be compared. before and after administration of multiple doses of SP2086
Measured: up to Day 9
The area under the plasma concentration-time curve (AUC) of SP2086
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Valsartan.
Measured: up to Day 9
The area under the plasma concentration-time curve (AUC) of SP2086 acid
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Valsartan.
Measured: up to Day 9
The area under the plasma concentration-time curve (AUC) of Valsartan
AUC (a measure of the body's exposure to Valsartan) will be compared before and after administration of multiple doses of SP2086
Measured: up to Day 9
Secondary outcomes (1)
The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817217
- Sponsor's protocol ID
- SP2086-111
- Status last verified
- Jan 2016
- First submitted
- 27 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Drug Interaction Study of SP2086 and Valsartan in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02817217
- Acronym / sponsor ID
- SP2086-111
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (estimated)
- First posted
- 29 Jun 2016 (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 purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SP2086 and Valsartan | Other | Drug: SP2086, Drug: Valsartan |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2.
Key exclusion criteria (6 listed)
- History of diabetes
- History of heart failure or renal insufficiency
- Urinary tract infections, or vulvovaginal mycotic infections
- History of or current clinically significant medical illness as determined by the Investigator
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
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 |
|---|---|---|
| SP2086SP2086 will be administered orally (by mouth) as 100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water. | Drug | SP2086 and Valsartan |
| ValsartanSP2086 will be administered orally (by mouth) as100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water. | Drug | SP2086 and Valsartan |
Primary outcome
The maximum plasma concentration (Cmax) of SP2086
Time frame: up to Day 9
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Valsartan
The maximum plasma concentration (Cmax) of SP2086 acid
Time frame: up to Day 9
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Valsartan
The maximum plasma concentration (Cmax) of Valsartan
Time frame: up to Day 9
Cmax (a measure of the body's exposure to Valsartan) will be compared. before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086
Time frame: up to Day 9
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Valsartan.
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Time frame: up to Day 9
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Valsartan.
The area under the plasma concentration-time curve (AUC) of Valsartan
Time frame: up to Day 9
AUC (a measure of the body's exposure to Valsartan) will be compared before and after administration of multiple doses of SP2086
1 secondary outcome
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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.
People's Liberation Army General Hospital of Chengdu Military Region
Chengdu, China
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 SP2086 and Valsartan in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Jun 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum plasma concentration (Cmax) of SP2086 (time frame: up to Day 9). The study lists 6 primary outcomes in all. 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 29 Jun 2016.