This is a Single Ascending Dose Tolerance Study

NCT01133574 | Terminated Phase 1

• 2 other identifiers: S354.1.0012009-017008-10
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B)

Conditions

Cognition Disorders

Keywords

Healthy volunteers; SLV354; Phase I; SRDT

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)

  1 week after each dose level

• Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B)

  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)

  1 week after each dose level

• Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A)

  1 week after each dose level

• Pharmacokinetic parameters (AUC and Cmax) after single oral dosing of 2-4 doses of SLV354 chosen (Part B)

  2 weeks after each dose

• Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B)

  2 weeks after each dose

Study Arms (14)

A1

EXPERIMENTAL

Part A, Parallel design Arm 1

Drug: SLV354 capsules

A2

EXPERIMENTAL

Part A, Parallel design Arm 2

Drug: SLV354 capsules

A3

EXPERIMENTAL

Part A, Parallel design Arm 3

Drug: SLV354 capsules

A4

EXPERIMENTAL

Part A, Parallel design Arm 4

Drug: SLV354 capsules

A5

EXPERIMENTAL

Part A, Parallel design Arm 5

Drug: SLV354 capsules

A6

EXPERIMENTAL

Part A, Parallel design Arm 6

Drug: SLV354 capsules

A7

EXPERIMENTAL

Part A, Parallel design Arm 7

Drug: SLV354 capsules

A8

EXPERIMENTAL

Part A, Parallel design Arm 8

Drug: SLV354 capsules

A9

PLACEBO COMPARATOR

Part A, Parallel design Arm 9

Drug: Placebo capsules

B1-1

EXPERIMENTAL

Part B, Cross-over design, Arm 1

Drug: SLV354 capsules

B1-2

EXPERIMENTAL

Part B, Cross-over design, Arm 2

Drug: SLV354 capsules

B2-1

EXPERIMENTAL

Part B, Cross-over design, Arm 3

Drug: SLV354 capsules

B2-2

EXPERIMENTAL

Part B, Cross-over design, Arm 4

Drug: SLV354 capsules

B3

PLACEBO COMPARATOR

Part B, Cross-over design, Arm 5

Drug: Placebo capsules

Interventions

SLV354 capsules DRUG

20 mg

A1

Placebo capsules DRUG

placebo

A9

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• relevant disease,
• treated with SLV354 before

Sponsors & Collaborators

• Abbott: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Site Reference ID/Investigator# 62002

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Beatrice Rendenbach-Mueller, PhD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 31, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 29, 2011

Record last verified: 2011-08

Locations

GB (1)