HealthyPhase 1NCT02461914
Evaluate the Pharmacokinetics of Warfarin When Coadministered With PEX168 in Healthy Adult Subjects
A Phase 1 study testing PEX168 and Warfarin in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial summary
To assess the effect of PEX168 doses on the pharmacokinetics of warfarin in healthy subjects.To provide a scientific basis for clinical drug combination of PEX168. To evaluated the impact of pharmacodynamics coadministrated hypodermic PEX168 and warfarin in healthy subjects. 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
- Healthy
- What is being tested?
- PEX168 and Warfarin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 13 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 male aged 18 to 45 years (including both ends) at the time of signing the informed consent.
- Weighing not less than 50kg，Body Mass Index (BMI)of 18 to 25kg/m2. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (Tbil) are within the normal range during screening;
- Estimated creatinine clearance (Clcr) ≥90ml / min calculated by the Cockcroft-Gault (CG) formula ;
- Capable of giving written informed consent, which included compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- The hepatitis B surface antigen, hepatitis C antibody, HIV antibody test positive;
- Having history of syncope, palpitations, bradycardia, tachycardia and other anomalies, or via a comprehensive physical examination , routine laboratory tests (blood count, blood biochemistry, urine, etc.), 12-lead ECG, abdominal B ultrasound, and other abnormalities and clinical significance persons before screening;
- Having Alcohol and drug abuse within first 6 months before screening;
- Smoked within 3 months before screening;
- In screening period, blood pressure greater than 140 / 90mmHg, retest after diagnosis or pulse rate is higher than 100bpm person;
- In screening period, ECG QTc> 450ms,diagnosed after retest;
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- Having a history of drug or allergic reactions or allergic constitution have hypersensitivity to any of the following:
- 1) Warfarin and / or any of its ingredients or other similar drugs . 2) PEX168
- 8. Before screening, having a history of cardiovascular disease or a history of pulmonary disease ;
- 9. The history of thromboembolic disease or undergoing surgery or gastrointestinal bleeding within 6 months before screening, or excessive bleeding or a history of heparin-induced thrombocytopenia have significant bleeding history or family history;
- 10.In screening period,platelet count or international normalized ratio (INR) or activated partial thromboplastin time (APTT) greater than the upper limit of the normal range or fibrinogen is less than the lower limit of the normal range;
- 11. In screening period , fasting triglycerides test result was greater than the upper limit of normal range;
- 12. Currently there is a history of liver disease or liver disease or a known hepatobiliary abnormalities (except asymptomatic gallstones);
- 13. Participate in blood donation and donation amount ≥400ml within three months before screening;
- 14. In screening period, having thyroid dysfunction or a history;
- 15. The history of gastrointestinal surgery before screening;
- 16. The history of pancreatitis;
- 17. History of cholecystitis gallbladder disease or other disease history;
- 18. The history of inflammatory bowel disease or a history of irritable bowel syndrome;
- 19. The history of Type 2 multiple endocrine neoplasia;
- 20. The history of medullary thyroid cancer;
- 21. The family has type 2 multiple endocrine fibromatosis or a history of medullary thyroid cancer;
- 22. Three months before screening, participated in any drug or medical device trials are (including placebo);
- 23. Using any of the tested drugs may affect prescription drugs , non-prescription drugs, herbal (especially ginseng, oral hypoglycemic agents) or multivitamin supplements persons;
- 24. Drinking medication or caffeine-containing xanthine food and beverage (listed in annex 3), strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors 2 days before screening.
- 25. Received GLP-1 analogs (e.g. exenatide) treatment;
- 26. Reluctant to take an effective method of contraception during the test;
- 27. Researchers believe any situation that might lead to any subject cannot complete the study or to the subject of this study bring significant risk.
About this study
Official title: An Open-label,Sequential,Single-site Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Polyethylene Glycol Loxenatide (PEX168) in Healthy Adult Subjects
To assess the effect of PEX168 doses on the pharmacokinetics of warfarin in healthy subjects.To provide a scientific basis for clinical drug combination of PEX168.
To evaluated the impact of pharmacodynamics coadministrated hypodermic PEX168 and warfarin in healthy subjects.
To assess the safety of single doses of warfarin administered with and without PEX168
Read the detailed description
This was an open-label, sequential, single-center study that evaluated the pharmacokinetics of warfarin when coadministered with PEX168 in healthy adult subjects. The total duration of each subject's participation in the study was approximately 13 weeks, which included up to a 14-day Screening Period, a 51-day Treatment Period, and an approximately 4-week Follow-up Period.
Center: This study was conducted at a single site in the first affiliate hospital of Zhejiang University.All subjects receives a single 5mg oral dose of warfarin on Day 1 followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 8 and a second single 5mg oral dose of warfarin on Day 44.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEX168Drug
Also called Polyethylene Glycol Loxenatide
200µg,injected subcutaneously,once a week.
WarfarinDrug
Also called Warfarin sodium tablets
5mg,oral,two times.
| Study group | Role | What they receive |
|---|---|---|
| Warfaring and PEX168(200µg) | Experimental | Warfarin: 5mg, oral Administration. PEX 168: 200µg,injected subcutaneously,once a week. Receives: Drug: PEX168; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure the plasma concentrations of warfarin
Plasma concentrations of warfarin, and to calculate the pharmacokinetic parameters: Tmax、Cmax、AUC0-t、AUC0-∞、λz ，t1/2、Vd/F、CL/F etc.
Measured: Baseline to Day51
Secondary outcomes (1)
Incidence of adverse events and serious adverse events
Measured: Baseline to Day78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study start1 Aug 2015
- Primary completion12 Dec 2015
- Study completion13 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Shentu, MD, Principal investigator, The first affiliate of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461914
- Sponsor's protocol ID
- PEX168-Ii
- Status last verified
- Jan 2016
- First submitted
- 26 May 2015
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label,Sequential,Single-site Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Polyethylene Glycol Loxenatide (PEX168) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02461914
- Acronym / sponsor ID
- PEX168-Ii
- Conditions
- Healthy
- Keywords
- Type 2 diabetes mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 12 Dec 2015 (actual)
- Study completion
- 13 Jul 2016 (actual)
- First posted
- 3 Jun 2015 (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.
To assess the effect of PEX168 doses on the pharmacokinetics of warfarin in healthy subjects.To provide a scientific basis for clinical drug combination of PEX168.
To evaluated the impact of pharmacodynamics coadministrated hypodermic PEX168 and warfarin in healthy subjects.
To assess the safety of single doses of warfarin administered with and without PEX168
Detailed description
This was an open-label, sequential, single-center study that evaluated the pharmacokinetics of warfarin when coadministered with PEX168 in healthy adult subjects. The total duration of each subject's participation in the study was approximately 13 weeks, which included up to a 14-day Screening Period, a 51-day Treatment Period, and an approximately 4-week Follow-up Period.
Center: This study was conducted at a single site in the first affiliate hospital of Zhejiang University.All subjects receives a single 5mg oral dose of warfarin on Day 1 followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 8 and a second single 5mg oral dose of warfarin on Day 44.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Warfaring and PEX168(200µg) | Experimental | Drug: PEX168, Drug: WarfarinWarfarin: 5mg, oral Administration. PEX 168: 200µg,injected subcutaneously,once a week. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male aged 18 to 45 years (including both ends) at the time of signing the informed consent.
- Weighing not less than 50kg，Body Mass Index (BMI)of 18 to 25kg/m2. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (Tbil) are within the normal range during screening;
- Estimated creatinine clearance (Clcr) ≥90ml / min calculated by the Cockcroft-Gault (CG) formula ;
- Capable of giving written informed consent, which included compliance with the requirements and restrictions listed in the consent form.
Key exclusion criteria (28 listed)
- The hepatitis B surface antigen, hepatitis C antibody, HIV antibody test positive;
- Having history of syncope, palpitations, bradycardia, tachycardia and other anomalies, or via a comprehensive physical examination , routine laboratory tests (blood count, blood biochemistry, urine, etc.), 12-lead ECG, abdominal B ultrasound, and other abnormalities and clinical significance persons before screening;
- Having Alcohol and drug abuse within first 6 months before screening;
- Smoked within 3 months before screening;
- In screening period, blood pressure greater than 140 / 90mmHg, retest after diagnosis or pulse rate is higher than 100bpm person;
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 |
|---|---|---|
| PEX168Also: Polyethylene Glycol Loxenatide200µg,injected subcutaneously,once a week. | Drug | Warfaring and PEX168(200µg) |
| WarfarinAlso: Warfarin sodium tablets5mg,oral,two times. | Drug | Warfaring and PEX168(200µg) |
Primary outcome
Composite measure the plasma concentrations of warfarin
Time frame: Baseline to Day51
Plasma concentrations of warfarin, and to calculate the pharmacokinetic parameters: Tmax、Cmax、AUC0-t、AUC0-∞、λz ，t1/2、Vd/F、CL/F etc.
1 secondary outcome
Incidence of adverse events and serious adverse events
Time frame: Baseline to Day78
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 24 Jan 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.
Jianzhong Shentu, MD principal investigator
The first affiliate of Zhejiang University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEX168 and Warfarin in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
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 28 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Composite measure the plasma concentrations of warfarin (time frame: Baseline to Day51). 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 24 Jan 2017.