Peripheral Arterial DiseasesPhase 1NCT02786043
PK Study to Evaluate the Effect of PLC on Healthy Chinese Subjects by Multiple-doses
A Phase 1 study testing Propionyl-L-Carnitine Hydrochloride in people with Peripheral Arterial Diseases, run by Lee's Pharmaceutical Limited.
Trial summary
The main objective is to evaluate the effect of Propionyl-L-Carnitine Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for market authorization registration Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Diseases
- What is being tested?
- Propionyl-L-Carnitine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jan 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex: Male and female of same proportion. Healthy individuals.
- Age: 19 to 45. Similar age.
- Weight: All subjects need to weigh ≥50 kg. BMI within 19~24 kg/m2. Similar weight between subjects.；
- Blood pressure: SBP 90-139mmHg，DBP 60-89 mmHg；
- Subjects need to understand and agree before the start of trial and signed the informed consent form.
- Subjects have to be able to communicate with the investigator and comply with the trial protocol.
Who cannot join
- Laboratory investigations:
- Any items of safety evaluation index baseline values considered to be clinically significant abnormal by the investigator before the study;
- Hepatitis B surface antigen positive;
- Hepatitis C antibody positive;
- HIV, Syphilis positive;
- During screening or 1st day of trial before drug administration, any ECG abnormality shown
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- Drug history:
- Taken any drugs that inhibit or induce hepatic metabolism of drug 1 month prior to the trial;
- Taken any drugs within 2 weeks prior to the trial (including prescription drugs, non-prescription drugs and Chinese herbal drugs);
- Past medical history and surgical history:
- Past medical history includes structural heart diseases, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmias, Torsade de pointes, ventricular tachycardia, Long QT syndrome or signs and symptoms of Long QT syndrome with family history (evidenced by genetic testing or relatives died of sudden cardiac death at a young age);
- Thyroid disease history or received thyroid surgery;
- Immune diseases history (e.g. thymus disorder history);
- Received surgery within 6 months prior to the trial;
- Serious gastrointestinal disease history (e.g. clinically significant gallbladder disease, known or suspected jaundice, hepatocellular adenoma, hepatic cavernous hemangioma or other hepatic disease);
- Any gastrointestinal, hepatic or renal diseases that affect drug absorption or metabolism within 6 months prior to the trial (excluded regardless resolved);
- Any serious cerebrovascular, respiratory, metabolic and neurological disease history;
- Hematological disease like clotting disorder;
- Tumor history;
- Hypokalemia, hypocalcemia according to the lower limit of reference range provided by the clinical laboratory;
- Lifestyle:
- Frequent alcohol intake within 6 months prior to the trial. Over 14 units of alcohol intake per week (1 unit = 17.7ml ethanol, 1 unit = 357 ml 5% alcohol beer or 44ml 40% liquor or 147 ml 12% alcohol wine);
- Smoke >1 cigarette per day within 3 months prior to the trial;
- Drug abuse history and taken drugs (marijuana, cocaine, opiates, benzodiazepines, amphetamines, barbiturates, methadone, tricyclic antidepressants, etc.) within 1 year prior to the trial;
- Drink excess tea, coffee or caffeine-containing drinks (more than 8 cups) per day 2 days before drug administration to 8 days after drug administration;
- Drink grapefruit juice 2 days before drug administration to 8 days after drug administration;
- Others:
- Did not consent to use effective contraceptive methods from enrollment to 3 months after drug administration;
- Hypersensitivity including known allergy to the excipients of the drug (microcrystalline cellulose, lactose, silica powder, sodium carboxymethyl starch, magnesium stearate);
- Participated in any other clinical trials within 3 months prior to the trial or planned to participate in any other clinical trials 1 month after enrollment to the last drug administration visit;
- Blood donation within 3 months prior to the trial or planned to donate blood 1 month after enrollment to the last drug administration visit;
- Any food allergy or special request to diet and cannot comply to unified diet;
- Subjects considered to be excluded by investigator;
- For female subjects, any following criteria met, apart from criteria above, should also be excluded:
- Taken oral contraceptive pills within 1 month prior to the trial;
- Long term use of estrogen or progesterone injection or implants within 6 months prior to the trial;
- Fertile female subjects without using contraceptive method 2 weeks prior to the trial;
- Fertile female subjects and spouse not consent to use following contraceptive method, condoms, intra-uterine device, etc. after enrollment to 3 months after drug administration;
- During pregnancy or lactation;
- Urine pregnancy test positive;
About this study
Official title: An Open-label, Single Arm, Self-controlled Safety and Pharmacokinetics Study to Evaluate the Effect of Propionyl L-carnitine Hydrochloride on Healthy Chinese Subjects by Diet and Multiple-doses
The main objective is to evaluate the effect of Propionyl-L-Carnitine Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for market authorization registration
Read the detailed description
This is a single group subject, open-label, self-controlled, 3 periods, multi-doses administration trial. 12 Healthy Chinese volunteers satisfying inclusion criteria were enrolled with equal number of male and female. Each subject goes through a 7-day Run-in period to eliminate the remaining L-carnitine like substance in the food to ensure the baseline level of endougenous L-Carnitien is stable；In period III, during the first 4 days，all healthy subjects take oral Propionyl-L-Carnitine 1g twice daily; on day 5, all healthy subjects take oral Propionyl-L-Carnitine 1g during fasting.
- Conditions
- Peripheral Arterial Diseases
- Being tested
- Propionyl-L-Carnitine Hydrochloride
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propionyl-L-Carnitine HydrochlorideDrug
1g twice a day on first 4 days and 1g/ day on day 5 during Phase III
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Drug: Propionyl-L-Carnitine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
To observe area under curve characteristics of Propionyl-L-Carnitine in single or multiple dose groups
Measured: Day 3 and 4, 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after drug administration on day 5
Secondary outcomes (1)
cumulative urine excretion rate
To compare the cumulative urine excretion rate in multiple dose with that in single dose
Measured: 0h-2h, 2-4h, 4-8h, 8-12h, 12-24h after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseasesStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heng-yan Qu, Principal investigator, National Clinical Trial Institution of Affiliated Hospital of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786043
- Sponsor's protocol ID
- Zhaoke-201506-PLC-multidose
- Status last verified
- Apr 2016
- First submitted
- 24 May 2016
- Last updated
- 30 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Arm, Self-controlled Safety and Pharmacokinetics Study to Evaluate the Effect of Propionyl L-carnitine Hydrochloride on Healthy Chinese Subjects by Diet and Multiple-doses
- ClinicalTrials.gov ID
- NCT02786043
- Acronym / sponsor ID
- Zhaoke-201506-PLC-multidose
- Conditions
- Peripheral Arterial Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 May 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 main objective is to evaluate the effect of Propionyl-L-Carnitine Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for market authorization registration
Detailed description
This is a single group subject, open-label, self-controlled, 3 periods, multi-doses administration trial. 12 Healthy Chinese volunteers satisfying inclusion criteria were enrolled with equal number of male and female. Each subject goes through a 7-day Run-in period to eliminate the remaining L-carnitine like substance in the food to ensure the baseline level of endougenous L-Carnitien is stable；In period III, during the first 4 days，all healthy subjects take oral Propionyl-L-Carnitine 1g twice daily; on day 5, all healthy subjects take oral Propionyl-L-Carnitine 1g during fasting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Propionyl-L-Carnitine Hydrochloride |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sex: Male and female of same proportion. Healthy individuals.
- Age: 19 to 45. Similar age.
- Weight: All subjects need to weigh ≥50 kg. BMI within 19~24 kg/m2. Similar weight between subjects.；
- Blood pressure: SBP 90-139mmHg，DBP 60-89 mmHg；
- Subjects need to understand and agree before the start of trial and signed the informed consent form.
Key exclusion criteria (40 listed)
- Any items of safety evaluation index baseline values considered to be clinically significant abnormal by the investigator before the study;
- Hepatitis B surface antigen positive;
- Hepatitis C antibody positive;
- HIV, Syphilis positive;
- During screening or 1st day of trial before drug administration, any ECG abnormality shown
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 |
|---|---|---|
| Propionyl-L-Carnitine Hydrochloride1g twice a day on first 4 days and 1g/ day on day 5 during Phase III | Drug | Single arm |
Primary outcome
Area Under Curve (AUC)
Time frame: Day 3 and 4, 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after drug administration on day 5
To observe area under curve characteristics of Propionyl-L-Carnitine in single or multiple dose groups
1 secondary outcome
cumulative urine excretion rate
Time frame: 0h-2h, 2-4h, 4-8h, 8-12h, 12-24h after drug administration
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 May 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.
Heng-yan Qu principal investigator
National Clinical Trial Institution of Affiliated Hospital of Military Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propionyl-L-Carnitine Hydrochloride in people with Peripheral Arterial Diseases, run by Lee's Pharmaceutical Limited.
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 6 inclusion and 40 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 May 2016. 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?
Area Under Curve (AUC) (time frame: Day 3 and 4, 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after drug administration on day 5). 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 May 2016.