Cognition DisordersPhase 1NCT01133574
This is a Single Ascending Dose Tolerance Study
A Phase 1 study testing SLV354 capsules in people with Cognition Disorders, run by Abbott at 1 site in United Kingdom.
Trial summary
This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B) Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorders
- What is being tested?
- SLV354 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Jul 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.0 to 28.0 kg/m2,
- systolic blood pressure 90-140 mmHg,
- diastolic blood pressure 50-90 mmHg,
- heart rate 50 100 beats/min (all inclusive),
- clinically normal safety ECG and laboratory results
Who cannot join
- relevant disease,
- treated with SLV354 before
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Site Reference ID/Investigator# 62002
London, SE1 9RT
About this study
Official title: A Double-Blind, Randomized, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of SLV354 After Oral Dose Administration in Healthy Adult Male Subjects
This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B)
Read the detailed description
The Part A of this study is a parallel design followed in a second part by a cross-over design
- Conditions
- Cognition Disorders
- Being tested
- SLV354 capsules, Placebo capsules
- Keywords
- Healthy volunteers, SLV354, Phase I, SRDT
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLV354 capsulesDrug
20 mg
SLV354 capsulesDrug
60 mg
SLV354 capsulesDrug
120 mg
SLV354 capsulesDrug
250 mg
SLV354 capsulesDrug
500 mg
SLV354 capsulesDrug
750 mg
SLV354 capsulesDrug
1000 mg
SLV354 capsulesDrug
1250 mg
Placebo capsulesDrug
placebo
SLV354 capsulesDrug
low dose group 1
SLV354 capsulesDrug
high dose group 1
SLV354 capsulesDrug
low dose group 2
SLV354 capsulesDrug
high dose group 2
Placebo capsulesDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Part A, Parallel design Arm 1 Receives: Drug: SLV354 capsules |
| A2 | Experimental | Part A, Parallel design Arm 2 Receives: Drug: SLV354 capsules |
| A3 | Experimental | Part A, Parallel design Arm 3 Receives: Drug: SLV354 capsules |
| A4 | Experimental | Part A, Parallel design Arm 4 Receives: Drug: SLV354 capsules |
| A5 | Experimental | Part A, Parallel design Arm 5 Receives: Drug: SLV354 capsules |
| A6 | Experimental | Part A, Parallel design Arm 6 Receives: Drug: SLV354 capsules |
| A7 | Experimental | Part A, Parallel design Arm 7 Receives: Drug: SLV354 capsules |
| A8 | Experimental | Part A, Parallel design Arm 8 Receives: Drug: SLV354 capsules |
| A9 | Placebo comparator | Part A, Parallel design Arm 9 Receives: Drug: Placebo capsules |
| B1-1 | Experimental | Part B, Cross-over design, Arm 1 Receives: Drug: SLV354 capsules |
| B1-2 | Experimental | Part B, Cross-over design, Arm 2 Receives: Drug: SLV354 capsules |
| B2-1 | Experimental | Part B, Cross-over design, Arm 3 Receives: Drug: SLV354 capsules |
| B2-2 | Experimental | Part B, Cross-over design, Arm 4 Receives: Drug: SLV354 capsules |
| B3 | Placebo comparator | Part B, Cross-over design, Arm 5 Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)
Measured: 1 week after each dose level
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B)
Measured: 2 weeks after each dose
Secondary outcomes (4)
Pharmacokinetic parameters (AUC and Cmax) after single ascending oral dosing of max. 8 doses of SLV354 ranging from 20 to 1250 mg (Part A)
Measured: 1 week after each dose level
Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A)
Measured: 1 week after each dose level
Pharmacokinetic parameters (AUC and Cmax) after single oral dosing of 2-4 doses of SLV354 chosen (Part B)
Measured: 2 weeks after each dose
Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B)
Measured: 2 weeks after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Part A completed successfully 22 July 2010, Part B will be separate PET study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition DisordersStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Beatrice Rendenbach-Mueller, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133574
- Sponsor's protocol ID
- S354.1.001
- Other IDs
- 2009-017008-10, 2009
- Status last verified
- Aug 2011
- First submitted
- 21 May 2010
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of SLV354 After Oral Dose Administration in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01133574
- Acronym / sponsor ID
- S354.1.001
- Conditions
- Cognition Disorders
- Keywords
- Healthy volunteers, SLV354, Phase I, SRDT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part A completed successfully 22 July 2010, Part B will be separate PET study
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 31 May 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 is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B)
Detailed description
The Part A of this study is a parallel design followed in a second part by a cross-over design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: SLV354 capsulesPart A, Parallel design Arm 1 |
| A2 | Experimental | Drug: SLV354 capsulesPart A, Parallel design Arm 2 |
| A3 | Experimental | Drug: SLV354 capsulesPart A, Parallel design Arm 3 |
| A4 | Experimental | Drug: SLV354 capsulesPart A, Parallel design Arm 4 |
| A5 | Experimental | Drug: SLV354 capsulesPart A, Parallel design Arm 5 |
| A6 | Experimental | Drug: SLV354 capsulesPart A, Parallel design Arm 6 |
| A7 | Experimental | Drug: SLV354 capsulesPart A, Parallel design Arm 7 |
| A8 | Experimental | Drug: SLV354 capsulesPart A, Parallel design Arm 8 |
| A9 | Placebo comparator | Drug: Placebo capsulesPart A, Parallel design Arm 9 |
| B1-1 | Experimental | Drug: SLV354 capsulesPart B, Cross-over design, Arm 1 |
| B1-2 | Experimental | Drug: SLV354 capsulesPart B, Cross-over design, Arm 2 |
| B2-1 | Experimental | Drug: SLV354 capsulesPart B, Cross-over design, Arm 3 |
| B2-2 | Experimental | Drug: SLV354 capsulesPart B, Cross-over design, Arm 4 |
| B3 | Placebo comparator | Drug: Placebo capsulesPart B, Cross-over design, Arm 5 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI 18.0 to 28.0 kg/m2,
- systolic blood pressure 90-140 mmHg,
- diastolic blood pressure 50-90 mmHg,
- heart rate 50 100 beats/min (all inclusive),
- clinically normal safety ECG and laboratory results
Key exclusion criteria (2 listed)
- relevant disease,
- treated with SLV354 before
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 |
|---|---|---|
| SLV354 capsules20 mg | Drug | A1 |
| SLV354 capsules60 mg | Drug | A2 |
| SLV354 capsules120 mg | Drug | A3 |
| SLV354 capsules250 mg | Drug | A4 |
| SLV354 capsules500 mg | Drug | A5 |
| SLV354 capsules750 mg | Drug | A6 |
| SLV354 capsules1000 mg | Drug | A7 |
| SLV354 capsules1250 mg | Drug | A8 |
| Placebo capsulesplacebo | Drug | A9 |
| SLV354 capsuleslow dose group 1 | Drug | B1-1 |
| SLV354 capsuleshigh dose group 1 | Drug | B1-2 |
| SLV354 capsuleslow dose group 2 | Drug | B2-1 |
| SLV354 capsuleshigh dose group 2 | Drug | B2-2 |
| Placebo capsulesplacebo | Drug | B3 |
Primary outcome
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)
Time frame: 1 week after each dose level
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B)
Time frame: 2 weeks after each dose
4 secondary outcomes
Pharmacokinetic parameters (AUC and Cmax) after single ascending oral dosing of max. 8 doses of SLV354 ranging from 20 to 1250 mg (Part A)
Time frame: 1 week after each dose level
Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A)
Time frame: 1 week after each dose level
Pharmacokinetic parameters (AUC and Cmax) after single oral dosing of 2-4 doses of SLV354 chosen (Part B)
Time frame: 2 weeks after each dose
Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B)
Time frame: 2 weeks after each dose
Results and safety
The study was stopped early (reason given: Part A completed successfully 22 July 2010, Part B will be separate PET study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 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.
Beatrice Rendenbach-Mueller, PhD study director
Abbott
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 SLV354 capsules in people with Cognition Disorders, run by Abbott at 1 site in United Kingdom.
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 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 29 Aug 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 Kingdom. 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 was stopped early (reason given: Part A completed successfully 22 July 2010, Part B will be separate PET study). 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?
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A) (time frame: 1 week after each dose level). The study lists 2 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 29 Aug 2011.