HealthyPhase 1NCT02451527
The Pharmacokinetic Study of the Combination of Digoxin and Polythylene Glycol Loxenatide Injection in Healthy Subjects
A Phase 1 study testing Digoxin and PEX168 in people with Healthy, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic study of the combination of digoxin and polythylene glycol loxenatide injection (PEX168) in healthy adults，and to provide scientific basis for clinical combination of PEX168 and drugs.This study is also to evaluate the safety and tolerability of mono-digoxin… 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?
- Digoxin and PEX168
- 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
- May 2015to 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 males aged from 18 to 45 years
- Have a body weight over 50kg, have a body mass index (BMI) 19-25 kg/m^2 (both inclusive)
- Alanine aminotransferase<50 U/L, aspartate aminotransferase<50 U/L, alkaline phosphatase and total bilirubin <1.5x the upper limit of normal
- According to Cockcroft-Gault, estimated Clcr≥90ml/min
- Able to comprehend and willing to sign the informed consent form
Who cannot join
- Hepatitis B surface antigen(+)， Hepatitis C virus antibody(+)，AIDS antibody（+）
- History of syncope, palpitations, bradycardia and tachycardia (for example any degree of atrioventricular block, left bundle branch block, right bundle branch block), or have an abnormal result of overall physical examination (vital signs, physical examination), routine laboratory assessment (hematology, biochemistry and urinalysis), 12-lead ECG and abdominal sonography (liver, gallbladder, pancreas, spleen, kidney)
- Have had an alcohol and substance abuse within 6 months of screening
- History of smoking within 3 months of screening
- BP>140/90 millimetres of mercury, or heart rate >100 bpm
- QT interval >450ms
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- History of drug-induced allergy or of hypersensitivity for digoxin and PEX168
- History of serious heart disease or lung disease
- Fasting triglyceride>1.5x the upper limit of normal
- Subjects with liver disease or have history of liver disease or abnormal liver and gallbladder conditions
- Donation of blood in excess of 400 mL within the 3 months of screening; or donation of blood within 1 month of screening; or received blood transfusions within 1 month of screening.
- Hypothyroidism
- Surgery of gastrointestinal tract
- History of pancreatitis
- History of cholecystitis or other gallbladder disease
- History of inflammatory bowel disease or irritable bowel syndrome
- History of MEN type 2 syndrome
- History of medullary thyroid carcinoma
- A family history of MEN type 2 syndrome and medullary thyroid carcinoma
- Have participated in clinical trials with drug or medical devices involved within 3 months of screening
- Have received any drug that may affect the study drugs within 2 weeks of screening, including prescribed drugs, over-counted drugs, Chinese traditional medicine or multivitamins
- History of grapefruit juice, cranberry, mango, foods and drinks of xanthine or caffeine, strenuous exercise, or any other factor affect the absorption, distribution, metabolism and excretion of the study drug within 2 days of screening
- Have received any glucagon-like peptide-1 mimetic compound(e.g., exenatide)
- Have been disagreed to use a reliable method of birth control during the study and for 6 months following the last dose of study drug
- History of any other condition, which in the opinion of the investigator, may prevent the subject from following and completing the protocol
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: An Open-label，Single-arm，Sequential，Single-center Clinical Trial of the Pharmacokinetic Study of the Combination of Digoxin and Polythylene Glycol Loxenatide Injection (PEX168) in Healthy Adult Subjects
The purpose of this study is to evaluate the pharmacokinetic study of the combination of digoxin and polythylene glycol loxenatide injection (PEX168) in healthy adults，and to provide scientific basis for clinical combination of PEX168 and drugs.This study is also to evaluate the safety and tolerability of mono-digoxin or digoxin plus PEX168.
Read the detailed description
This will be an open-label, single-arm, sequential, single-center clinical trial. 16 healthy males will be admitted to the clinical facility on Day -1, the day prior to the start of dosing. The subjects will be observed in clinic twice: Day -1 to 8 and Day 37 to 44. Subjects will receive a single dose of digoxin on Day 1 followed by 5 weekly subcutaneously injected doses of PEX168 and a second single dose of digoxin on Day 38. To determine the pharmacokinetic parameters of digoxin after drug administration alone and after multiple doses of PEX168, blood and urine samples will be collected after each dose of digoxin and tested by the laboratory.The subjects will be discharged on Day 8 and Day 44. Approximately 28 days after the last discharge, the subjects will be called for a post study visit.
- Conditions
- Healthy
- Being tested
- Digoxin, PEX168
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigoxinDrug
Also called Digoxine, Digoxinum, Lanoxin, Vanoxin
Digoxin 0.5mg tablet by mouth on Day 1 and Day 38
PEX168Drug
Also called Polythylene Glycol Loxenatide Injection
PEX168 in subcutaneous injection on Day8，15，22，29 and Day 36
| Study group | Role | What they receive |
|---|---|---|
| Digoxin and PEX168 | Experimental | A single dose of 0.5mg digoxin administered on Day 1 followed by 5 weekly subcutaneous injections of a single dose of 200ug PEX168, followed by a further single dose of 0.5mg digoxin on Day 38. Receives: Drug: Digoxin; Drug: PEX168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of pharmacokinetic (PK) parameters of digoxin with and without PEX168 in plasma and urine (cmax, t 1/2)
Maximum observed concentration in plasma(cmax); apparent terminal elimination half-life in plasma(t1/2).
Measured: Day 1 through Day 44
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Day 1 through Day 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionJul 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 First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bingyin Shi, MD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451527
- Sponsor's protocol ID
- 2013L02060
- Status last verified
- Aug 2016
- First submitted
- 12 May 2015
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label，Single-arm，Sequential，Single-center Clinical Trial of the Pharmacokinetic Study of the Combination of Digoxin and Polythylene Glycol Loxenatide Injection (PEX168) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02451527
- Acronym / sponsor ID
- 2013L02060
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 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.
The purpose of this study is to evaluate the pharmacokinetic study of the combination of digoxin and polythylene glycol loxenatide injection (PEX168) in healthy adults，and to provide scientific basis for clinical combination of PEX168 and drugs.This study is also to evaluate the safety and tolerability of mono-digoxin or digoxin plus PEX168.
Detailed description
This will be an open-label, single-arm, sequential, single-center clinical trial. 16 healthy males will be admitted to the clinical facility on Day -1, the day prior to the start of dosing. The subjects will be observed in clinic twice: Day -1 to 8 and Day 37 to 44. Subjects will receive a single dose of digoxin on Day 1 followed by 5 weekly subcutaneously injected doses of PEX168 and a second single dose of digoxin on Day 38. To determine the pharmacokinetic parameters of digoxin after drug administration alone and after multiple doses of PEX168, blood and urine samples will be collected after each dose of digoxin and tested by the laboratory.The subjects will be discharged on Day 8 and Day 44. Approximately 28 days after the last discharge, the subjects will be called for a post study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digoxin and PEX168 | Experimental | Drug: Digoxin, Drug: PEX168A single dose of 0.5mg digoxin administered on Day 1 followed by 5 weekly subcutaneous injections of a single dose of 200ug PEX168, followed by a further single dose of 0.5mg digoxin on Day 38. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males aged from 18 to 45 years
- Have a body weight over 50kg, have a body mass index (BMI) 19-25 kg/m^2 (both inclusive)
- Alanine aminotransferase<50 U/L, aspartate aminotransferase<50 U/L, alkaline phosphatase and total bilirubin <1.5x the upper limit of normal
- According to Cockcroft-Gault, estimated Clcr≥90ml/min
- Able to comprehend and willing to sign the informed consent form
Key exclusion criteria (25 listed)
- Hepatitis B surface antigen(+)， Hepatitis C virus antibody(+)，AIDS antibody（+）
- History of syncope, palpitations, bradycardia and tachycardia (for example any degree of atrioventricular block, left bundle branch block, right bundle branch block), or have an abnormal result of overall physical examination (vital signs, physical examination), routine laboratory assessment (hematology, biochemistry and urinalysis), 12-lead ECG and abdominal sonography (liver, gallbladder, pancreas, spleen, kidney)
- Have had an alcohol and substance abuse within 6 months of screening
- History of smoking within 3 months of screening
- BP>140/90 millimetres of mercury, or heart rate >100 bpm
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 |
|---|---|---|
| DigoxinAlso: Digoxine, Digoxinum, Lanoxin, VanoxinDigoxin 0.5mg tablet by mouth on Day 1 and Day 38 | Drug | Digoxin and PEX168 |
| PEX168Also: Polythylene Glycol Loxenatide InjectionPEX168 in subcutaneous injection on Day8，15，22，29 and Day 36 | Drug | Digoxin and PEX168 |
Primary outcome
Composite of pharmacokinetic (PK) parameters of digoxin with and without PEX168 in plasma and urine (cmax, t 1/2)
Time frame: Day 1 through Day 44
Maximum observed concentration in plasma(cmax); apparent terminal elimination half-life in plasma(t1/2).
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 1 through Day 44
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 30 Nov 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.
Bingyin Shi, MD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 Digoxin and PEX168 in people with Healthy, run by First Affiliated Hospital Xi'an Jiaotong University 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 25 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 30 Nov 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?
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 of pharmacokinetic (PK) parameters of digoxin with and without PEX168 in plasma and urine (cmax, t 1/2) (time frame: Day 1 through Day 44). 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 30 Nov 2016.