PharmacokineticsPhase 1NCT01082146
RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE
A Phase 1 study testing Lurasidone in people with Pharmacokinetics and Metabolism, run by Sumitomo Pharma America, Inc. at 1 site in United States.
Trial summary
This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state 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
- Pharmacokinetics, Metabolism
- What is being tested?
- Lurasidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2008
- 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
- within a BMI range of 18.0 to 28.0 kg/m2 inclusive;
- males will either be sterile or agree to use from Check-in until 45 days following Study Completion/Discharge approved methods of contraception
- able to comprehend and willing to sign an Informed Consent Form (ICF);
- able to void urine on a daily basis and 1 to 2 bowel movements per day.
- able to swallow 60 mL of dosing suspension.
Who cannot join
- history or presence of an abnormal ECG
- participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in.
- exposure to significant radiation within 12 months prior to Check-in;
- participation in any other investigational study drug trial
- use of any prescription medications/products within 14 days prior to Check-in
- use of any inhibitors or inducers of CYP3A4 taken within 30 days prior to Check-in, including but not limited to drugs listed in Appendix E;
- receipt of blood products within 2 months prior to Check-in;
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Global Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Issthiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Health Male Subjects
This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state
Read the detailed description
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Isothiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Healthy Male Subjects.
- Conditions
- Pharmacokinetics, Metabolism
- Being tested
- Lurasidone
- Keywords
- pharmacokinetics, lurasidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
40 mg suspension, PO, for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone | Experimental | LURASIDONE 40mg Receives: Drug: Lurasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the pharmacokinetics (PK) of a postprandial single dose of 40 mg (150 Ci 5.55 Megabecquerels (MBq)) [Isothiazolyl-3-14C-Lurasidone and its metabolites
Measured: 28 days
To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).
Measured: 28 days
To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).
Measured: 28 days
Secondary outcomes (3)
To assess the safety of 40 mg [Isothiazolyl-3-14C]-Lurasidone
Measured: 28 days
To characterize and identify metabolites of Lurasidone in serum and urine
Measured: 28 days
To determine serum concentrations of Lurasidone
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startAug 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Bohn, MD, Principal investigator, Covance Global Clinical Research Unit Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082146
- Sponsor's protocol ID
- D1050262
- Status last verified
- Apr 2014
- First submitted
- 5 Mar 2010
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Issthiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Health Male Subjects
- ClinicalTrials.gov ID
- NCT01082146
- Acronym / sponsor ID
- D1050262
- Conditions
- Pharmacokinetics, Metabolism
- Keywords
- pharmacokinetics, lurasidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 8 Mar 2010 (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.
This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state
Detailed description
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Isothiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Healthy Male Subjects.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lurasidone | Experimental | Drug: LurasidoneLURASIDONE 40mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- within a BMI range of 18.0 to 28.0 kg/m2 inclusive;
- males will either be sterile or agree to use from Check-in until 45 days following Study Completion/Discharge approved methods of contraception
- able to comprehend and willing to sign an Informed Consent Form (ICF);
- able to void urine on a daily basis and 1 to 2 bowel movements per day.
- able to swallow 60 mL of dosing suspension.
Key exclusion criteria (7 listed)
- history or presence of an abnormal ECG
- participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in.
- exposure to significant radiation within 12 months prior to Check-in;
- participation in any other investigational study drug trial
- use of any prescription medications/products within 14 days prior to Check-in
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 |
|---|---|---|
| Lurasidone40 mg suspension, PO, for 7 days | Drug | Lurasidone |
Primary outcome
To assess the pharmacokinetics (PK) of a postprandial single dose of 40 mg (150 Ci 5.55 Megabecquerels (MBq)) [Isothiazolyl-3-14C-Lurasidone and its metabolites
Time frame: 28 days
To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).
Time frame: 28 days
To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).
Time frame: 28 days
3 secondary outcomes
To assess the safety of 40 mg [Isothiazolyl-3-14C]-Lurasidone
Time frame: 28 days
To characterize and identify metabolites of Lurasidone in serum and urine
Time frame: 28 days
To determine serum concentrations of Lurasidone
Time frame: 28 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 3 Apr 2014.
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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.
John Bohn, MD principal investigator
Covance Global Clinical Research Unit 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 Lurasidone in people with Pharmacokinetics and Metabolism, run by Sumitomo Pharma America, 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 5 inclusion and 7 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 3 Apr 2014. 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. 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?
To assess the pharmacokinetics (PK) of a postprandial single dose of 40 mg (150 Ci 5.55 Megabecquerels (MBq)) [Isothiazolyl-3-14C-Lurasidone and its metabolites (time frame: 28 days). The study lists 3 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 3 Apr 2014.