HealthyPhase 1NCT00581191
Study Evaluating the Safety and Tolerability of Single Ascending Dose (SAD) SLV-351 in Healthy Subjects
A Phase 1 study testing SLV-351 in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
Safety and tolerability of single oral doses in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SLV-351
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Mar 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men, aged 18-50 years.
- Women of nonchildbearing potential, aged 18-50 years.
Who cannot join
None listed.
About this study
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SLV-351 Administered Orally to Healthy Subjects
Safety and tolerability of single oral doses in healthy subjects.
- Conditions
- Healthy
- Being tested
- SLV-351
- Keywords
- SAD, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLV-351Drug
SLV-351 capsules taken once
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 0.5 mg SLV-351 (fasted) Receives: Drug: SLV-351 |
| 2 | Experimental | 1 mg SLV-351 (fasted) Receives: Drug: SLV-351 |
| 3 | Experimental | 2.5 mg SLV-351 (fasted) Receives: Drug: SLV-351 |
| 4 | Experimental | 5 mg SLV-351 (fasted) Receives: Drug: SLV-351 |
| 5 | Experimental | 10 mg SLV-351 (fasted) Receives: Drug: SLV-351 |
| 6 | Experimental | 15 mg SLV-351 (fasted) Receives: Drug: SLV-351 |
| 7 | Experimental | 20 mg SLV-351 (fasted) Receives: Drug: SLV-351 |
| 8 | Experimental | 30 mg SLV-351 (fasted) Receives: Drug: SLV-351 |
| 9 | Experimental | xx mg SLV-351 (fasted and fed) Receives: Drug: SLV-351 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safet and tolerability
Measured: 35 days
Secondary outcomes (1)
PK and PD
Measured: 35 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 startJan 2008
- Primary completionMar 2008
- Study completionMar 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581191
- Sponsor's protocol ID
- 3233A1-1000
- Status last verified
- Aug 2009
- First submitted
- 21 Dec 2007
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SLV-351 Administered Orally to Healthy Subjects
- ClinicalTrials.gov ID
- NCT00581191
- Acronym / sponsor ID
- 3233A1-1000
- Conditions
- Healthy
- Keywords
- SAD, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Jan 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 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.
Safety and tolerability of single oral doses in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SLV-3510.5 mg SLV-351 (fasted) |
| 2 | Experimental | Drug: SLV-3511 mg SLV-351 (fasted) |
| 3 | Experimental | Drug: SLV-3512.5 mg SLV-351 (fasted) |
| 4 | Experimental | Drug: SLV-3515 mg SLV-351 (fasted) |
| 5 | Experimental | Drug: SLV-35110 mg SLV-351 (fasted) |
| 6 | Experimental | Drug: SLV-35115 mg SLV-351 (fasted) |
| 7 | Experimental | Drug: SLV-35120 mg SLV-351 (fasted) |
| 8 | Experimental | Drug: SLV-35130 mg SLV-351 (fasted) |
| 9 | Experimental | Drug: SLV-351xx mg SLV-351 (fasted and fed) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men, aged 18-50 years.
- Women of nonchildbearing potential, aged 18-50 years.
Key exclusion criteria (0 listed)
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-351SLV-351 capsules taken once | Drug | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
Primary outcome
Safet and tolerability
Time frame: 35 days
1 secondary outcome
PK and PD
Time frame: 35 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 4 Aug 2009.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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-351 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 0 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 4 Aug 2009. 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?
Safet and tolerability (time frame: 35 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 4 Aug 2009.