HealthyPhase 1NCT01475981
Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects
A Phase 1 study of Healthy, run by Shionogi Inc. at 1 site in United States.
Trial summary
The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2010
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of 18-30 kg/m2 (inclusive)
- Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit
Who cannot join
- History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
- Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen), within 4 weeks prior to the Day before dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized,Double-blind,Placebo-controlled,Ascending Dose Part Evaluating Safety,Tolerability and Pharmacokinetics (PK) of JTK-853 (Fasted/Fed) and Randomized,Open-label,Crossover Part Evaluating Food Effect on PK in Healthy Male Subjects
The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects.
- Conditions
- Healthy
- Being tested
- JTK-853 or Placebo
- Keywords
- JTK-853, single dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTK-853 or PlaceboDrug
Tablets, single dose, fasted, fed or high-fat fed condition
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 JTK-853 (fasted condition) | Experimental | Not described Receives: Drug: JTK-853 or Placebo |
| Dose 2 JTK-853 (fasted condition) | Experimental | Not described Receives: Drug: JTK-853 or Placebo |
| Dose 3 JTK-853 (fasted condition) | Experimental | Not described Receives: Drug: JTK-853 or Placebo |
| Dose 2 JTK-853 (fed condition) | Experimental | Not described Receives: Drug: JTK-853 or Placebo |
| Dose 3 JTK-853 (fed condition) | Experimental | Not described Receives: Drug: JTK-853 or Placebo |
| Dose 4 JTK-853 (fed condition) | Experimental | Not described Receives: Drug: JTK-853 or Placebo |
| Dose 5 JTK-853 (fed condition) | Experimental | Not described Receives: Drug: JTK-853 or Placebo |
| Dose 6 JTK-853 (fed condition) | Experimental | Not described Receives: Drug: JTK-853 or Placebo |
| Dose 7 JTK-853 (fed condition) | Experimental | Not described Receives: Drug: JTK-853 or Placebo |
| Dose 5 JTK-853 (high-fat fed condition) | Experimental | Not described Receives: Drug: JTK-853 or Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: JTK-853 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: 1 week
Maximum concentration (Cmax) of JTK-853 and metabolite M2
Measured: 1 week
Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2
Measured: 1 week
Area under the concentration-time curve from the time of dosing to the last quantifiable time point (AUClast) for JTK-853 and metabolite M2
Measured: 1 week
Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2
Measured: 1 week
Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shoji Hoshino, D.V.M, Study director, Shionogi Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475981
- Sponsor's protocol ID
- AK853-U-09-001
- Status last verified
- Nov 2011
- First submitted
- 9 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Double-blind,Placebo-controlled,Ascending Dose Part Evaluating Safety,Tolerability and Pharmacokinetics (PK) of JTK-853 (Fasted/Fed) and Randomized,Open-label,Crossover Part Evaluating Food Effect on PK in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01475981
- Acronym / sponsor ID
- AK853-U-09-001
- Conditions
- Healthy
- Keywords
- JTK-853, single dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Nov 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.
The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Dose 1 JTK-853 (fasted condition) | Experimental | Drug: JTK-853 or Placebo |
| Dose 2 JTK-853 (fasted condition) | Experimental | Drug: JTK-853 or Placebo |
| Dose 3 JTK-853 (fasted condition) | Experimental | Drug: JTK-853 or Placebo |
| Dose 2 JTK-853 (fed condition) | Experimental | Drug: JTK-853 or Placebo |
| Dose 3 JTK-853 (fed condition) | Experimental | Drug: JTK-853 or Placebo |
| Dose 4 JTK-853 (fed condition) | Experimental | Drug: JTK-853 or Placebo |
| Dose 5 JTK-853 (fed condition) | Experimental | Drug: JTK-853 or Placebo |
| Dose 6 JTK-853 (fed condition) | Experimental | Drug: JTK-853 or Placebo |
| Dose 7 JTK-853 (fed condition) | Experimental | Drug: JTK-853 or Placebo |
| Dose 5 JTK-853 (high-fat fed condition) | Experimental | Drug: JTK-853 or Placebo |
| Placebo | Placebo comparator | Drug: JTK-853 or Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) of 18-30 kg/m2 (inclusive)
- Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit
Key exclusion criteria (2 listed)
- History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
- Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen), within 4 weeks prior to the Day before dosing
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 |
|---|---|---|
| JTK-853 or PlaceboTablets, single dose, fasted, fed or high-fat fed condition | Drug | Dose 1 JTK-853 (fasted condition), Dose 2 JTK-853 (fasted condition), Dose 2 JTK-853 (fed condition), Dose 3 JTK-853 (fasted condition), Dose 3 JTK-853 (fed condition), Dose 4 JTK-853 (fed condition), Dose 5 JTK-853 (fed condition), Dose 5 JTK-853 (high-fat fed condition), Dose 6 JTK-853 (fed condition), Dose 7 JTK-853 (fed condition), Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: 1 week
Maximum concentration (Cmax) of JTK-853 and metabolite M2
Time frame: 1 week
Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2
Time frame: 1 week
Area under the concentration-time curve from the time of dosing to the last quantifiable time point (AUClast) for JTK-853 and metabolite M2
Time frame: 1 week
Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2
Time frame: 1 week
Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2
Time frame: 1 week
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 22 Nov 2011.
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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.
Shoji Hoshino, D.V.M study director
Shionogi 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 of Healthy, run by Shionogi Inc. at 1 site in United States.
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 2 inclusion and 2 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 22 Nov 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 United States. 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. Some participants in this study may receive a placebo. 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?
Number of subjects with adverse events (time frame: 1 week). The study lists 6 primary outcomes in all. 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 22 Nov 2011.