PharmacokineticsPhase 1OC-DDINCT00549666
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
A Phase 1 study testing Lurasidone 40 mg and Ortho Tri-Cyclen in people with Pharmacokinetics, run by Sumitomo Pharma America, Inc. at 1 site in United States.
Trial summary
A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Lurasidone 40 mg and Ortho Tri-Cyclen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2007
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is female between 18 and 40 years of age
- Female subjects of reproductive potential will demonstrate a negative serum β-human chorionic gonadotropin level consistent with the non-gravid state at the screening visit
- Subject agrees to take the triphasic oral contraceptive, Ortho Tri-Cyclen™, throughout the study.
- Subject has a history of regular menstrual periods with no substantial breakthrough bleeding episodes while taking Ortho Tri-Cyclen™.
- Subject has a body mass index that is < 33 kg/m2 (see Appendix 1).
- Subject is judged to be in good health
- Subject must have a negative hepatiti and HIV antibody at screening.
- Subject has no clinically significant abnormality on screening ECG.
Who cannot join
- Subject has a history of major GI abnormalities/peptic ulceration, hematological, genitourinary, cardiovascular (including hypertension), renal, hepatic, pulmonary, psychiatric, endocrine (including diabetes) or metabolic (including glaucoma), neurologic or cerebrovascular disease, or any history of cancer.
- Subject has systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg at screening.
- Subject has a history of any chronic and/or active hepatic disease including elevations of serum transaminases, hepatitis, biliary tract disease, or a history of any gastrointestinal surgery.
- Subject has any other acute or chronic medical or psychiatric condition that, in the opinion of the investigator, would limit the patient safety or confound the results of the study.
- Subject has an ECG at screening with PR > 240 msec; QRS complex > 120 msec; QTcB > 450; or any significant morphologic changes other than nonspecific T-wave changes.
- Subject is currently a user of any illicit drugs (including "recreational use") including marijuana, or has recently used illicit drugs, or has a history of drug or alcohol dependence in the past year or abuse within the last 3 months.
Show all 11Show fewer
- Subject consumes excessive amounts of alcohol
- Subject has had surgery within last 12 weeks, donated a unit of blood (within 4 weeks), or participated in another clinical study within 30 days of screening.
- Subjects with hypertension, hyperlipidemia, and diabetes should also be excluded. (See package circular under "Contraindications")
- Subject has clinically significant abnormalities at screening clinical examination or laboratory safety tests
- Subject has a prolactin level of over 200 ng/mL at screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Global Clinical Pharmacology, Inc.
San Diego, California, 92123
About this study
A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen
- Conditions
- Pharmacokinetics
- Being tested
- Lurasidone 40 mg, Placebo 40 mg, Ortho Tri-Cyclen
- Keywords
- OC DDI, lurasidone, Latuda, schizophenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone 40 mgDrug
Lurasidone 40 mg days 12-21 once daily
Placebo 40 mgDrug
Placebo 40 mg once daily during treatment period
Ortho Tri-CyclenDrug
Ortho Tri-Cyclen during 28-day lead in period
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone 40 mg | Experimental | Not described Receives: Drug: Lurasidone 40 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo 40 mg |
| Ortho Tri-Cyclen | Active comparator | Not described Receives: Drug: Ortho Tri-Cyclen |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionDec 2007
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549666
- Sponsor's protocol ID
- D1050246
- Acronym
- OC-DDI
- Status last verified
- Sep 2011
- First submitted
- 24 Oct 2007
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT00549666
- Acronym / sponsor ID
- OC-DDI / D1050246
- Conditions
- Pharmacokinetics
- Keywords
- OC DDI, lurasidone, Latuda, schizophenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 26 Oct 2007 (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 Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lurasidone 40 mg | Experimental | Drug: Lurasidone 40 mg |
| Placebo | Placebo comparator | Drug: Placebo 40 mg |
| Ortho Tri-Cyclen | Active comparator | Drug: Ortho Tri-Cyclen |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is female between 18 and 40 years of age
- Female subjects of reproductive potential will demonstrate a negative serum β-human chorionic gonadotropin level consistent with the non-gravid state at the screening visit
- Subject agrees to take the triphasic oral contraceptive, Ortho Tri-Cyclen™, throughout the study.
- Subject has a history of regular menstrual periods with no substantial breakthrough bleeding episodes while taking Ortho Tri-Cyclen™.
- Subject has a body mass index that is < 33 kg/m2 (see Appendix 1).
Key exclusion criteria (11 listed)
- Subject has a history of major GI abnormalities/peptic ulceration, hematological, genitourinary, cardiovascular (including hypertension), renal, hepatic, pulmonary, psychiatric, endocrine (including diabetes) or metabolic (including glaucoma), neurologic or cerebrovascular disease, or any history of cancer.
- Subject has systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg at screening.
- Subject has a history of any chronic and/or active hepatic disease including elevations of serum transaminases, hepatitis, biliary tract disease, or a history of any gastrointestinal surgery.
- Subject has any other acute or chronic medical or psychiatric condition that, in the opinion of the investigator, would limit the patient safety or confound the results of the study.
- Subject has an ECG at screening with PR > 240 msec; QRS complex > 120 msec; QTcB > 450; or any significant morphologic changes other than nonspecific T-wave changes.
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 |
|---|---|---|
| Lurasidone 40 mgLurasidone 40 mg days 12-21 once daily | Drug | Lurasidone 40 mg |
| Placebo 40 mgPlacebo 40 mg once daily during treatment period | Drug | Placebo |
| Ortho Tri-CyclenOrtho Tri-Cyclen during 28-day lead in period | Drug | Ortho Tri-Cyclen |
Primary outcome
Not reported in the source record.
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 14 Sep 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.
Medical Director, MD study director
Sumitomo Pharma America, 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 40 mg and Ortho Tri-Cyclen in people with Pharmacokinetics, 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 8 inclusion and 11 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 14 Sep 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.
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 14 Sep 2011.