Peripheral Arterial DiseasePhase 1NCT02786069
A Single-dose Escalation Safety and PK Study for PLC in Healthy Chinese
A Phase 1 study testing Propionyl L-carnitine Hydrochloride in people with Peripheral Arterial Disease, run by Lee's Pharmaceutical Limited.
Trial summary
The main objective is to evaluate the effect of single dose 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 Disease
- What is being tested?
- Propionyl L-carnitine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 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
- Gender: male and female, healthy subjects;
- Age: 19 to 45 years of age, of similar age;
- Weight: The weight of all subjects need ≥50 kg, body mass index [BMI = weight (kg) / height 2 (m 2)] within 19 to 24 kg / m2 range of weight as close as possible;
- Blood pressure: SBP 90-139mmHg, DBP 60-89 mmHg;
- The subjects must be informed consent before the trial, and voluntarily signed a written informed consent form;
- Subjects can be good communication with researchers and to complete the test in accordance with program requirements.
Who cannot join
- Subjects having one or more cannot be selected for the trial:
- Laboratory parameters:
- Before testing the safety evaluation of any one of the researchers baseline values considered clinically significant abnormalities;
- Hepatitis B surface antigen test positive;
- Hepatitis C antibody test positive;
- AIDS, syphilis testing positive;
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- Pre-medication ECG abnormal situation at screening period or trial day 1 as followings:
- QTc> 450 ms (QTc using Bazett correction formula QTc = QT / RR0.5 computing);
- Ⅱ ° atrioventricular or Ⅲ ° atrioventricular block;
- heart rate <45 beats / min or> 100 beats / min;
- Room PR of> 200 ms or <110 ms;
- QRS complex> 120 ms;
- Pathological Q waves (in accordance with Q wave> 40 ms defined);
- Ventricular pre-excitation syndrome;
- Medication history:
- 1 month before the trial orally used any inhibition or induction of hepatic drug metabolism of drugs;
- 2 weeks before the trial taking any medications (including prescription and non-prescription drugs and herbal preparations) persons;
- Disease history and surgical history:
- Past history of suffering from structural heart disease, arrhythmias, heart failure, history of history, history of myocardial infarction, angina pectoris, history cannot be explained, fast ventricular reverse history, history of ventricular tachycardia, QT prolongation syndrome or have a history of long QT syndrome symptoms and family history (as evidenced by genetic or close relative at a young age due to cardiac causes of sudden death show);
- Have a history of thyroid disease or previously treated thyroid surgery;
- A history of immune system (such as a history of thymus disease);
- Within six months before the trial had received surgery;
- Have a history of severe digestive system diseases (such as having a significant clinical significance of gallbladder disease, known or suspected jaundice, hepatocellular adenoma, cavernous hemangioma of the liver and other liver diseases);
- Within six months before the trial have suffered from gastrointestinal or metabolic liver and kidney disease that can affect drug absorption (whether or not cured were excluded);
- Have any serious cardiovascular system, respiratory system, metabolic system and the nervous system a history;
- Suffering from blood coagulation disorders and other diseases system;
- Have a history of cancer;
- According to a clinical laboratory reference range limits, with hypokalemia, hypocalcemia;
- Lifestyle:
- Within six months before the trial frequent drinkers, that drinking more than 14 units of alcohol a week (1 unit = 17.7 ml ethanol, or 1 unit = 357 ml alcohol content of 5% of the amount of alcohol in beer or 44 ml of 40% spirits or 147 ml alcohol content of 12% of the wine);
- Within three months before the trial daily cigarette consumption> one;
- Before the trial, 1 year history of drug abuse and drug taking too (such as marijuana, cocaine, opiates, benzodiazepines, amphetamines, barbiturates, tricyclic antidepressants, etc.);
- Before treatment 2 days to 8 days after drug overdose drinking tea, coffee and / or beverages containing caffeine (8 cups or more) every day;
- Eight days before treatment were drinking grapefruit juice and other beverages to medication after two days;
- Others:
- Do not agree to take effective contraceptive measures after medication within 3 months;
- Allergies, including known allergies history to this drug excipients (microcrystalline cellulose, lactose, silica powder, sodium carboxymethyl starch, magnesium stearate);
- Within three months before the trial participated in any clinical trials or after the enrollment of this trial until 1 month after the end of the last follow-up visit to participate in other clinical trials;
- Before the trial within three months have donated blood, or planned to do so after until 1 month of the end of last follow-up visit;
- Have any food allergies or special dietary requirements, cannot comply with unified diets;
- The researchers judgments that those who should not be included;
- Female subjects in addition to the above criteria, fulfilling any one of the following criteria must be excluded:
- Taking oral contraceptives before 1 month of trial;
- The use of long-acting estrogen or progestin injections or implants before 6 months of trial;
- Women of childbearing age failed to take adequate contraceptive measures before 2 weeks of trial;
- Women of childbearing age and their spouses do not agree to take following contraception measures within three months after medication: condoms, IUD;
- Pregnancy, lactation ;
- Urine pregnancy test was positive;
About this study
Official title: A Single-arm, Self-controlled, Three-period Dynamics Single-dose Escalation Safety and Pharmacokinetics Study for Propionyl L-carnitine Hydrochloride Tablets of Healthy Subjects in China
The main objective is to evaluate the effect of single dose 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
Before the official start of the study, to determine the appropriate dosing interval and a preliminary assessment of drug safety, first carried out the pre-trial, 4 subjects with different gender in half, after 7 days of run-in period, collect baseline background sampling point at day 4, no medication but water intake. At day 8 fasting oral propionyl L-carnitine hydrochloride tablets 0.5g, according to pre-designed schedule for blood samples, urine samples and clinical indicators, provide a reference for official trial.
Official trial is a single, open label, self-controlled, three-period, dose escalation, period fasting single oral administration trial. 12 chinese healthy adult subject met the inclusion criteria 12 people, each gender in half. Each subject first pass 7 days of run-in period, to eliminate the residual substances in food L-carnitine, stable baseline level of endogenous L-carnitine class substance within the subject; at day 4 was baseline sampling point, tno medication but water intake; at day 8 (1st period day 1) fasting oral propionyl L-carnitine hydrochloride tablets 1g; at day 12 (2nd period of day 1) fasting oral hydrochloride propionyl L-carnitine tablets 2g; the first 16 days (3rd period day 1) fasting oral propionyl L-carnitine hydrochloride tablets 4g.Throughout the trial period, control the subjects' diet, eating only allowed as far as possible food without substance L-carnitine class and drink boiled water,diet at sampling day 4, 8, 12, 16 need to be fixed consistently. Every 4 days of dosing interval washout period.
Subject need to follow blood, urine collection and diet control as required by protocol before the day of run-in period. During the trial should avoid vigorous exercise, meanwhile to avoid long-time bedding.
- Conditions
- Peripheral Arterial Disease
- 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
500mg/ tablet; for oral administration, 1 dosage form is set for this trial: 1g, 2g and 4g.
| 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 hydrochloride in single dose oral 1, 2, 4g
Measured: 0h, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after administration
Secondary outcomes (1)
cumulative excretion percentage
To estimate cumulative excretion percentage from the urine drug concentration in single dose oral 1, 2, 4g propionyl L-carnitine hydrochloride tablets
Measured: after drinking 0-2h, 2-4h, 4-8h, 8-12h, 12-24h for 4ml urine collection
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 DiseaseStudies 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
- 16 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
- NCT02786069
- Sponsor's protocol ID
- Zhaoke-201506-PLC-single dose
- 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
- A Single-arm, Self-controlled, Three-period Dynamics Single-dose Escalation Safety and Pharmacokinetics Study for Propionyl L-carnitine Hydrochloride Tablets of Healthy Subjects in China
- ClinicalTrials.gov ID
- NCT02786069
- Acronym / sponsor ID
- Zhaoke-201506-PLC-single dose
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 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 single dose 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
Before the official start of the study, to determine the appropriate dosing interval and a preliminary assessment of drug safety, first carried out the pre-trial, 4 subjects with different gender in half, after 7 days of run-in period, collect baseline background sampling point at day 4, no medication but water intake. At day 8 fasting oral propionyl L-carnitine hydrochloride tablets 0.5g, according to pre-designed schedule for blood samples, urine samples and clinical indicators, provide a reference for official trial.
Official trial is a single, open label, self-controlled, three-period, dose escalation, period fasting single oral administration trial. 12 chinese healthy adult subject met the inclusion criteria 12 people, each gender in half. Each subject first pass 7 days of run-in period, to eliminate the residual substances in food L-carnitine, stable baseline level of endogenous L-carnitine class substance within the subject; at day 4 was baseline sampling point, tno medication but water intake; at day 8 (1st period day 1) fasting oral propionyl L-carnitine hydrochloride tablets 1g; at day 12 (2nd period of day 1) fasting oral hydrochloride propionyl L-carnitine tablets 2g; the first 16 days (3rd period day 1) fasting oral propionyl L-carnitine hydrochloride tablets 4g.Throughout the trial period, control the subjects' diet, eating only allowed as far as possible food without substance L-carnitine class and drink boiled water,diet at sampling day 4, 8, 12, 16 need to be fixed consistently. Every 4 days of dosing interval washout period.
Subject need to follow blood, urine collection and diet control as required by protocol before the day of run-in period. During the trial should avoid vigorous exercise, meanwhile to avoid long-time bedding.
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)
- Gender: male and female, healthy subjects;
- Age: 19 to 45 years of age, of similar age;
- Weight: The weight of all subjects need ≥50 kg, body mass index [BMI = weight (kg) / height 2 (m 2)] within 19 to 24 kg / m2 range of weight as close as possible;
- Blood pressure: SBP 90-139mmHg, DBP 60-89 mmHg;
- The subjects must be informed consent before the trial, and voluntarily signed a written informed consent form;
Key exclusion criteria (48 listed)
- Before testing the safety evaluation of any one of the researchers baseline values considered clinically significant abnormalities;
- Hepatitis B surface antigen test positive;
- Hepatitis C antibody test positive;
- AIDS, syphilis testing positive;
- Pre-medication ECG abnormal situation at screening period or trial day 1 as followings:
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 Hydrochloride500mg/ tablet; for oral administration, 1 dosage form is set for this trial: 1g, 2g and 4g. | Drug | Single arm |
Primary outcome
Area Under Curve (AUC)
Time frame: 0h, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after administration
To observe area under curve characteristics of propionyl L-carnitine hydrochloride in single dose oral 1, 2, 4g
1 secondary outcome
cumulative excretion percentage
Time frame: after drinking 0-2h, 2-4h, 4-8h, 8-12h, 12-24h for 4ml urine collection
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 Disease, 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 48 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: 0h, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after administration). 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.