Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:
NCT01590901
First received: January 11, 2012
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral doses of probucol in healthy male subjects.


Condition Intervention Phase
Healthy
Drug: Probucol
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects

Further study details as provided by Otsuka Beijing Research Institute:

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: Day 1, 3, 5, 7, 9, 11, 12, 13, 14 ] [ Designated as safety issue: Yes ]

    Pharmacokinetic parameters:

    Day 1 (Plasma PK parameters over the 24h dosing period): Cmax, Cmax1, Cmax2, tmax1, tmax2, AUC (0-10)h, AUC (10-24)h, AUC24h, C24h; Day3,5,7,9,11,12,13:C24h; Day 14: Cmax, Cmax1, Cmax2, tmax1, tmax2, AUC (0-10)h, AUC (10-24)h, AUC24h, C24h, Clast, tlast, t1/2,z,Lambdaz, DF, CL/F, Vz/F, AUC_%Extrap;

    Accumulation evaluation parameters:

    Rpred, R14,ac(AUC24h), R14,ac(Cmax), R14,ac(C24h), R14,ac[AUC(0-10h)], R14,ac[AUC(10-24h)], R14,ac(Cmax1), R14,ac(Cmax2).



Enrollment: 12
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
probucol in healthy male subjects
multiple oral doses of probucol in single group of healthy male subjects
Drug: Probucol
250mg (1 tablet) bid. p.o for 14 consecutive days
Other Name: Lorelco

Detailed Description:

This is a single dose, single period, multiple administration, open-labeled trial in one investigation center.

The screening examination will be completed from Day -14 to Day -2 before investigational medicinal product (IMP) administration. The subjects will be hospitalized on Day -1. From Day 1 (the next day), the subjects will receive probucol twice daily (BID). for 14 consecutive days. On Day 18, the subjects can be discharged after the safety evaluation. The follow-up visit will occur on Day 6, 9, 12, 15, 19, 27 (totally 41 days) after the final dosing day.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Chinese.
  2. Gender: Male.
  3. Age 20 to 40 years, (at time of informed consent).
  4. Body mass index [BMI, body weight (kg) / height (m)2] between 19 and 26 kg/m2, inclusive.
  5. Nonsmokers (or former smokers): Urinary cotinine level satisfying the criteria for a nonsmoker established by the trial site (at time of screening examination).
  6. Subjects judged by the investigator to be healthy based on the medical history, physical examination, vital signs, 12 lead ECG, the results of serological test (HIV/HCV Ab, HBsAg and Syphilis Ab) and clinical laboratory tests, etc.

Exclusion Criteria:

  1. Subjects with hypersensitivity or a history of hypersensitivity to any drug (any prescription or over-the-counter [OTC] drug)
  2. Subjects who meet any of the following lipid criteria in the fasting state (at time of screening examination)

    • LDL-C: ≥ 140 mg/dL
    • TC: ≥ 220 mg/dL
    • HDL-C: < 40 mg/dL
    • TG: ≥ 150 mg/dL

      • LDL-C value will be directly measured or calculated by the Friedewald formula. Friedewald Formula: LDL-C = TC - HDL-C - TG/5 (When TG value is less than 400 mg/dL) LDL-C value will be directly measured when TG value is 400 mg/dL or greater.
  3. Subjects with electrocardiogram (ECG) results showing AV block or with both QTc and QRS width outside the standard values of the ECG laboratory (at time of screening examination)
  4. Subjects with alcohol or drug dependence or a history of drug abuse
  5. Subjects who have a positive result in an infectious disease test or urine drug test (at time of screening examination)
  6. Use of any of the following within the specified period prior to scheduled investigational medicinal product (IMP) administration

    • All other prescription and OTC drugs (within 2 weeks prior to scheduled IMP administration)
    • Alcohol and caffeine-containing products (within 1 week prior to scheduled IMP administration)
  7. Use of any other investigational drug within 16 weeks prior to scheduled IMP administration in the present trial
  8. Plasmapheresis or plateletpheresis within 2 weeks or whole blood collection (blood donation, etc) cumulatively exceeding 200 mL within 4 weeks, 400 mL within 12 weeks, or 1200 mL within 1 year prior to scheduled IMP administration
  9. Subjects whose body weight is less than 50 kg (at time of screening examination)
  10. Subjects who are scheduled for examination or treatment at any other hospital or clinic during the trial period
  11. Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01590901

Locations
China
Clinical Pharmacology Research Center, Peking Union Medical College Hospital
Beijing, China
Sponsors and Collaborators
Otsuka Beijing Research Institute
Investigators
Principal Investigator: Pei Hu, PHD Clinical Pharmacology Research Center of Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier: NCT01590901     History of Changes
Other Study ID Numbers: 009-11-803-01
Study First Received: January 11, 2012
Last Updated: June 4, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Otsuka Beijing Research Institute:
Pharmacokinetics
Probucol
healthy male subjects

Additional relevant MeSH terms:
Probucol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014