Type 2 Diabetes MellitusPhase 1NCT02447601
Evaluate the Pharmacokinetics of Simvastatin When Coadministered With PEX168 in Healthy Adult Subjects
A Phase 1 study testing PEX168 and Simvastatin in people with Type 2 Diabetes Mellitus, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To assess the effect of PEX168 doses on the pharmacokinetics of simvastatin(as determined by simvastation acid) in healthy subjects. To assess the safety of single doses of simvastation administered with and without PEX168 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 Mellitus
- What is being tested?
- PEX168 and Simvastatin
- 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
- 1 siteChina
- Study dates
- 30 Mar 2015to 11 Aug 2015
- 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
- An individual who met all of the following criteria was eligible for the study.
- 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.
- No history of cardiovascular, liver, kidney, gastrointestinal, neuropsychiatric and other diseases, no history of drug allergy.
- Capable of giving written informed consent, which included compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Known for any study drug allergy (PEX168, simvastatin) or similar drug allergy (GLP-1 receptor agonists, GLP-1 analogue, statins) or allergic constitution;
- Having Alcohol and drug abuse within first 6 months before screening;
- Smoked within 3 months before screening;
- Received GLP-1 receptor agonists, GLP-1 analogs, DPP-IV inhibitors, or any other similar structure drug for treatment before screening;
- Following a thorough medical examination, clinically significant abnormalities were found;
- In screening period, blood pressure greater than 140 / 90mmHg, retest after diagnosis or pulse rate is higher than 100bpm person;
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- In screening period, ECG QTc> 450ms, diagnosed after retest;
- In screening period, serum creatinine or urine protein is abnormal, and were determined to be clinically significant by the investigator;
- In screening period, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), γ- glutamate GGT (γ-GT), total bilirubin (Tbil) is greater than the normal range limit, and investigator determines to have clinical significance;
- In screening period, creatine kinase (CK) exceeds the upper limit of the normal range, and judged by the investigator to be clinical significant;
- In screening period, having thyroid dysfunction;
- Before screening there is a history of medullary thyroid cancer;
- Having any surgery (including the impact of gastric emptying of gastrointestinal surgery) within 6 months before screening;
- Participate in blood donation and donation amount ≥400ml within three months before screening, or who participate in blood donation or blood transfusion within a month;
- Using any of the tested drugs may affect prescription drugs, nonprescription drugs, herbs, food (such as grapefruit juice) or food supplements persons 2 weeks before screening;
- 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.
- Any clinically significant by the investigator determined that acute diseases before Screening occurred within a month too;
- There is a history of pancreatitis or acute pancreatitis before screening;
- Having dyslipidemia, coronary heart disease, and a history of high cholesterol before screening.
- There are lung disease histories, history of chronic liver and gallbladder disease, cholecystitis history, history of bladder disease, a history of colon inflammation before screening.
- Within three months before screening participated in any drug or medical device clinical trials were (including placebo);
- Hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test positive;
- Reluctant to take effective contraceptive methods of contraception. During the trial, there was family planning within six months after their spouses during the trial or the last dose (first 33 days);
- The investigator believe that any situation that might lead to any subject cannot be completed or to the subject of this study bring significant risk.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center (SMHC)
Shanghai, Shanghai Municipality, 200122
About this study
Official title: An Open-label,Sequential,Single-site Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Polyethylene Glycol Loxenatide (PEX168) in Healthy Adult Subjects
To assess the effect of PEX168 doses on the pharmacokinetics of simvastatin(as determined by simvastation acid) in healthy subjects.
To assess the safety of single doses of simvastation administered with and without PEX168
Read the detailed description
This was an open-label, sequential, single-center study that evaluated the pharmacokinetics of simvastatin when coadministered with PEX168 in healthy adult subjects. The total duration of each subject's participation in the study was approximately 10 weeks, which included up to a 14-day Screening Period, a 34-day Treatment Period, and an approximately 4-week Follow-up Period.
Center: This study was conducted at a single site in Shanghai Mental Health Center (SMHC)of China Treatment.All subjects receives a single 40-mg oral dose of simvastatin on Day 1 followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 3 and a second single 40-mg oral dose of simvastatin on Day 33.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- PEX168, Simvastatin
- 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.
PEX168Drug
Also called Polyethylene Glycol Loxenatide
200µg,injected subcutaneously,once a week.
SimvastatinDrug
Also called Shujiangzhi
40mg,oral,two times
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin and PEX168(200µg) | Experimental | Simvastatin: 40mg, oral Administration. PEX 168: 200µg,injected subcutaneously,once a week. Receives: Drug: PEX168; Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of simvastatin and simvastatin acid.
Plasma concentrations of simvastatin and simvastatin acid, and to calculate the pharmacokinetic parameters: Tmax, Cmax, AUC0-t, AUC0-∞, λz, t1 / 2, Vd / F, CL / F, etc.
Measured: Baseline to Day34
Secondary outcomes (1)
Incidence of adverse events and serious adverse events
Measured: Baseline to Day67
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study start30 Mar 2015
- Primary completion14 May 2015
- Study completion11 Aug 2015
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.
- 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
- Huafang Li, MD, Principal investigator, Shanghai Mental Health Center (SMHC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447601
- Sponsor's protocol ID
- PEX168-Ik
- Other IDs
- PEX168-Ik
- Status last verified
- May 2015
- First submitted
- 25 Mar 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 Simvastatin When Coadministered With Polyethylene Glycol Loxenatide (PEX168) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02447601
- Acronym / sponsor ID
- PEX168-Ik
- Conditions
- 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
- 30 Mar 2015 (actual)
- Primary completion
- 14 May 2015 (actual)
- Study completion
- 11 Aug 2015 (actual)
- First posted
- 19 May 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 simvastatin(as determined by simvastation acid) in healthy subjects.
To assess the safety of single doses of simvastation administered with and without PEX168
Detailed description
This was an open-label, sequential, single-center study that evaluated the pharmacokinetics of simvastatin when coadministered with PEX168 in healthy adult subjects. The total duration of each subject's participation in the study was approximately 10 weeks, which included up to a 14-day Screening Period, a 34-day Treatment Period, and an approximately 4-week Follow-up Period.
Center: This study was conducted at a single site in Shanghai Mental Health Center (SMHC)of China Treatment.All subjects receives a single 40-mg oral dose of simvastatin on Day 1 followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 3 and a second single 40-mg oral dose of simvastatin on Day 33.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simvastatin and PEX168(200µg) | Experimental | Drug: PEX168, Drug: SimvastatinSimvastatin: 40mg, 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 (5 listed)
- An individual who met all of the following criteria was eligible for the study.
- 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.
- No history of cardiovascular, liver, kidney, gastrointestinal, neuropsychiatric and other diseases, no history of drug allergy.
- Capable of giving written informed consent, which included compliance with the requirements and restrictions listed in the consent form.
Key exclusion criteria (24 listed)
- Known for any study drug allergy (PEX168, simvastatin) or similar drug allergy (GLP-1 receptor agonists, GLP-1 analogue, statins) or allergic constitution;
- Having Alcohol and drug abuse within first 6 months before screening;
- Smoked within 3 months before screening;
- Received GLP-1 receptor agonists, GLP-1 analogs, DPP-IV inhibitors, or any other similar structure drug for treatment before screening;
- Following a thorough medical examination, clinically significant abnormalities were found;
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 | Simvastatin and PEX168(200µg) |
| SimvastatinAlso: Shujiangzhi40mg,oral,two times | Drug | Simvastatin and PEX168(200µg) |
Primary outcome
Plasma concentrations of simvastatin and simvastatin acid.
Time frame: Baseline to Day34
Plasma concentrations of simvastatin and simvastatin acid, 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 Day67
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.
Huafang Li, MD principal investigator
Shanghai Mental Health Center (SMHC)
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 PEX168 and Simvastatin in people with Type 2 Diabetes Mellitus, run by Jiangsu Hansoh Pharmaceutical 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 5 inclusion and 24 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.
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?
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?
Plasma concentrations of simvastatin and simvastatin acid. (time frame: Baseline to Day34). 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.