Healthy Adult MalePhase 1NCT01423435
Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males
A Phase 1 study testing TRK-100STP in people with Healthy Adult Male and Pharmacokinetics of TRK-100-STP, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and South Korean non-elderly healthy adult males. Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male, Pharmacokinetics of TRK-100-STP
- What is being tested?
- TRK-100STP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2011to Sep 2011
- 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 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight: =<50.0 to 80.0> kg
- BMI: =<17.6 to 26.4>
- Subjects whose condition an investigator/subinvestigator has confirmed to be healthy by the date of drug administration, based on the screening test results
Who cannot join
- Subjects who received an investigational drug within 120 days prior to the screening test in other clinical trials or post-marketing studies
- Subjects who had 400 mL whole blood drawing within 90 days prior to the screening test, who had 200 mL whole blood drawing within 30 days prior to the screening test, or had component blood drawing within 14 days prior to the screening test
- Subjects who has received or will receive any drug treatment including over the counter (OTC) drugs within 7 days prior to the day of confinement
- Subjects whose vital signs are out of the standard level in one of the following parameters at the time of the screening test or the day of confinement: blood pressure, pulse rate, body temperature, and 12-lead ECG
- Subjects who have had upper Gastro-Intestinal (GI) symptoms within 7 days prior to the day of confinement (1 day prior to the drug administration): nausea, vomiting, or stomachache
- Subjects who have complications or history of liver diseases: viral hepatitis or chronic bronchitis
Show all 14Show fewer
- Subjects who have complications or history of Cardio Vascular (CV) diseases: chronic heart failure, angina, or arrythmia that needs treatment
- Subjects who have complications or history of respiratory diseases: severe bronchial asthma or chronic bronchitis. History of pediatric asthma is not included
- Subjects who have complications or history of respiratory diseases: severe peptic ulceration or gastro-esophageal reflux disease. History of appendicitis is not included
- Subjects who have complications or history of renal diseases: acute renal failure, glomerulonephritis, or interstitial nephritis. History of calculus is not included
- Subjects who have complications or history of cerebrovascular diseases including cerebral infarction
- Subjects who have complications or history of malignant tumors
- Subjects in whom the daily amount of alcohol or smoking is excessive
- Subjects who have received beraprost
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males -
A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and South Korean non-elderly healthy adult males.
- Being tested
- TRK-100STP
- Keywords
- TRK-100STP, PK, beraprost sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRK-100STPDrug
Also called beraprost, Careload LA, YM533
oral
| Study group | Role | What they receive |
|---|---|---|
| Japanese | Experimental | Not described Receives: Drug: TRK-100STP |
| Chinese | Experimental | Not described Receives: Drug: TRK-100STP |
| South Korean | Experimental | Not described Receives: Drug: TRK-100STP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax), area under the serum concentration-time curve (AUC) and terminal half-life (t1/2)
Measured: Up to 48 hours
Secondary outcomes (1)
Safety assessed by the incidence of adverse events, vital signs, 12-lead electrocardiograms (ECGs) and lab tests
Measured: Up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Toray Industries, Inc
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423435
- Sponsor's protocol ID
- 533-CL-006
- Status last verified
- Oct 2011
- First submitted
- 24 Aug 2011
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males -
- ClinicalTrials.gov ID
- NCT01423435
- Acronym / sponsor ID
- 533-CL-006
- Keywords
- TRK-100STP, PK, beraprost sodium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Toray Industries, Inc
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Aug 2011 (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.
A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and South Korean non-elderly healthy adult males.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Japanese | Experimental | Drug: TRK-100STP |
| Chinese | Experimental | Drug: TRK-100STP |
| South Korean | Experimental | Drug: TRK-100STP |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight: =<50.0 to 80.0> kg
- BMI: =<17.6 to 26.4>
- Subjects whose condition an investigator/subinvestigator has confirmed to be healthy by the date of drug administration, based on the screening test results
Key exclusion criteria (14 listed)
- Subjects who received an investigational drug within 120 days prior to the screening test in other clinical trials or post-marketing studies
- Subjects who had 400 mL whole blood drawing within 90 days prior to the screening test, who had 200 mL whole blood drawing within 30 days prior to the screening test, or had component blood drawing within 14 days prior to the screening test
- Subjects who has received or will receive any drug treatment including over the counter (OTC) drugs within 7 days prior to the day of confinement
- Subjects whose vital signs are out of the standard level in one of the following parameters at the time of the screening test or the day of confinement: blood pressure, pulse rate, body temperature, and 12-lead ECG
- Subjects who have had upper Gastro-Intestinal (GI) symptoms within 7 days prior to the day of confinement (1 day prior to the drug administration): nausea, vomiting, or stomachache
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 |
|---|---|---|
| TRK-100STPAlso: beraprost, Careload LA, YM533oral | Drug | Chinese, Japanese, South Korean |
Primary outcome
Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax), area under the serum concentration-time curve (AUC) and terminal half-life (t1/2)
Time frame: Up to 48 hours
1 secondary outcome
Safety assessed by the incidence of adverse events, vital signs, 12-lead electrocardiograms (ECGs) and lab tests
Time frame: Up to 6 days
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 4 Oct 2011.
Related trials for Healthy Adult Male
Not yet recruitingPhase 1
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults
Focal Onset Seizure
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
Recruiting
Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Brown Rice
Healthy Adult Males, Healthy Adult Females
RecruitingPhase 1
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
Renal Impairment, Healthy Volunteers
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.
Use Central Contact study chair
Astellas Pharma Inc
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 TRK-100STP in people with Healthy Adult Male and Pharmacokinetics of TRK-100-STP, run by Astellas Pharma Inc at 1 site in Japan.
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 3 inclusion and 14 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 4 Oct 2011. 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 Japan. 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?
Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax), area under the serum concentration-time curve (AUC) and terminal half-life (t1/2) (time frame: Up to 48 hours). 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 4 Oct 2011.