PK Study to Evaluate the Effect of PLC on Healthy Chinese Subjects by Multiple-doses

NCT02786043 | Completed Phase 1

• 1 other identifier: Zhaoke-201506-PLC-multidose
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Peripheral Arterial Diseases

Outcome Measures

Primary Outcomes (1)

• Area Under Curve (AUC)

  To observe area under curve characteristics of Propionyl-L-Carnitine in single or multiple dose groups

  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

  0h-2h, 2-4h, 4-8h, 8-12h, 12-24h after drug administration

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: Propionyl-L-Carnitine Hydrochloride

Interventions

Propionyl-L-Carnitine Hydrochloride DRUG

1g twice a day on first 4 days and 1g/ day on day 5 during Phase III

Single arm

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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);

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Heng-yan Qu

  National Clinical Trial Institution of Affiliated Hospital of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 30, 2016
• Study Start: June 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 30, 2016

Record last verified: 2016-04