A Single-dose Escalation Safety and PK Study for PLC in Healthy Chinese

NCT02786069 | Completed Phase 1

• 1 other identifier: Zhaoke-201506-PLC-single dose
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Area Under Curve (AUC)

  To observe area under curve characteristics of propionyl L-carnitine hydrochloride in single dose oral 1, 2, 4g

  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

  after drinking 0-2h, 2-4h, 4-8h, 8-12h, 12-24h for 4ml urine collection

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: Propionyl L-carnitine Hydrochloride

Interventions

Propionyl L-carnitine Hydrochloride DRUG

500mg/ tablet; for oral administration, 1 dosage form is set for this trial: 1g, 2g and 4g.

Single arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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:

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