HealthyPhase 1NCT00581243
Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients
A Phase 1 study testing SLV-313 SR in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Healthy
- What is being tested?
- SLV-313 SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 1 May 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men, aged 18-50 years old
- Women, aged 18-50 years old
Who cannot join
- Non-lactating women, aged 18-50 years old
- Non-pregnant women, aged 18-50 years old
About this study
Official title: An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SLV-313 Sustained-Release (SR) Tablets Administered Orally to Subjects With Schizophrenia and Schizoaffective Disorder
Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.
- Conditions
- Healthy
- Being tested
- SLV-313 SR
- Keywords
- Safety,Tolerability, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLV-313 SRDrug
sustained relase tablets taken once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2 mg SLV-313 SR (fixed dose) Receives: Drug: SLV-313 SR |
| 2 | Experimental | 5 mg SLV-313 SR (fixed dose) Receives: Drug: SLV-313 SR |
| 3 | Experimental | 10 mg SLV-313 SR (fixed dose) Receives: Drug: SLV-313 SR |
| 4 | Experimental | xx mg SLV-313 SR (titration) Receives: Drug: SLV-313 SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe safety and tolerability
Measured: 25 days
Secondary outcomes (1)
PK and PD profile
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study start1 Jan 2008
- Primary completion1 May 2008
- Study completion1 May 2008
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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581243
- Sponsor's protocol ID
- 3170A1-01001
- Status last verified
- Apr 2022
- First submitted
- 21 Dec 2007
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SLV-313 Sustained-Release (SR) Tablets Administered Orally to Subjects With Schizophrenia and Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00581243
- Acronym / sponsor ID
- 3170A1-01001
- Conditions
- Healthy
- Keywords
- Safety,Tolerability, Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 May 2008 (actual)
- Study completion
- 1 May 2008 (actual)
- First posted
- 27 Dec 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.
Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SLV-313 SR2 mg SLV-313 SR (fixed dose) |
| 2 | Experimental | Drug: SLV-313 SR5 mg SLV-313 SR (fixed dose) |
| 3 | Experimental | Drug: SLV-313 SR10 mg SLV-313 SR (fixed dose) |
| 4 | Experimental | Drug: SLV-313 SRxx mg SLV-313 SR (titration) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men, aged 18-50 years old
- Women, aged 18-50 years old
Key exclusion criteria (2 listed)
- Non-lactating women, aged 18-50 years old
- Non-pregnant women, aged 18-50 years old
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 |
|---|---|---|
| SLV-313 SRsustained relase tablets taken once daily for 14 days | Drug | 1, 2, 3, 4 |
Primary outcome
Observe safety and tolerability
Time frame: 25 days
1 secondary outcome
PK and PD profile
Time frame: 25 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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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 Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SLV-313 SR in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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: stopped early, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
Observe safety and tolerability (time frame: 25 days). 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 May 2022.