HealthyPhase 1NCT01590901
Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects
A Phase 1 study testing Probucol in people with Healthy, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral doses of probucol in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probucol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Jan 2013
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese.
- Gender: Male.
- Age 20 to 40 years, (at time of informed consent).
- Body mass index [BMI, body weight (kg) / height (m)2] between 19 and 26 kg/m2, inclusive.
- Nonsmokers (or former smokers): Urinary cotinine level satisfying the criteria for a nonsmoker established by the trial site (at time of screening examination).
- 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.
Who cannot join
- Subjects with hypersensitivity or a history of hypersensitivity to any drug (any prescription or over-the-counter [OTC] drug)
- 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
Show all 18Show fewer
- 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.
- 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)
- Subjects with alcohol or drug dependence or a history of drug abuse
- Subjects who have a positive result in an infectious disease test or urine drug test (at time of screening examination)
- 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)
- Use of any other investigational drug within 16 weeks prior to scheduled IMP administration in the present trial
- 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
- Subjects whose body weight is less than 50 kg (at time of screening examination)
- Subjects who are scheduled for examination or treatment at any other hospital or clinic during the trial period
- Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Pharmacology Research Center, Peking Union Medical College Hospital
Beijing
About this study
Official title: The Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects
The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral doses of probucol in healthy male subjects.
Read the 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.
- Conditions
- Healthy
- Being tested
- Probucol
- Keywords
- Pharmacokinetics, Probucol, healthy male subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbucolDrug
Also called Lorelco
250mg (1 tablet) bid. p.o for 14 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| probucol in healthy male subjects | Other | multiple oral doses of probucol in single group of healthy male subjects Receives: Drug: Probucol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
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).
Measured: Day 1, 3, 5, 7, 9, 11, 12, 13, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pei Hu, PHD, Principal investigator, Clinical Pharmacology Research Center of Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590901
- Sponsor's protocol ID
- 009-11-803-01
- Status last verified
- Jun 2013
- First submitted
- 11 Jan 2012
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01590901
- Acronym / sponsor ID
- 009-11-803-01
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Probucol, healthy male subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 May 2012 (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 Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral doses of probucol in healthy male subjects.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| probucol in healthy male subjects | Other | Drug: Probucolmultiple oral doses of probucol in single group of healthy male subjects |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chinese.
- Gender: Male.
- Age 20 to 40 years, (at time of informed consent).
- Body mass index [BMI, body weight (kg) / height (m)2] between 19 and 26 kg/m2, inclusive.
- Nonsmokers (or former smokers): Urinary cotinine level satisfying the criteria for a nonsmoker established by the trial site (at time of screening examination).
Key exclusion criteria (18 listed)
- Subjects with hypersensitivity or a history of hypersensitivity to any drug (any prescription or over-the-counter [OTC] drug)
- Subjects who meet any of the following lipid criteria in the fasting state (at time of screening examination)
- 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)
- Subjects with alcohol or drug dependence or a history of drug abuse
- Subjects who have a positive result in an infectious disease test or urine drug test (at time of screening examination)
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 |
|---|---|---|
| ProbucolAlso: Lorelco250mg (1 tablet) bid. p.o for 14 consecutive days | Drug | probucol in healthy male subjects |
Primary outcome
Pharmacokinetic parameters
Time frame: Day 1, 3, 5, 7, 9, 11, 12, 13, 14
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).
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 5 Jun 2013.
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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.
Pei Hu, PHD principal investigator
Clinical Pharmacology Research Center of Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Probucol in people with Healthy, run by Otsuka Beijing Research Institute at 1 site in China.
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 18 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 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pharmacokinetic parameters (time frame: Day 1, 3, 5, 7, 9, 11, 12, 13, 14). 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 5 Jun 2013.