This is a Single Ascending Dose Tolerance Study

Abbott

Status and phase: Terminated; Phase 1

Conditions: Cognition Disorders

Treatments: Drug: SLV354 capsules; Drug: Placebo capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01133574

2009-017008-10 (EudraCT Number)

S354.1.001

Details and patient eligibility

About

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

Full description

The Part A of this study is a parallel design followed in a second part by a cross-over design

Enrollment: 47 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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

Exclusion Criteria

• relevant disease,
• treated with SLV354 before

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

47 participants in 14 patient groups, including a placebo group

A1

Experimental group

Description:

Part A, Parallel design Arm 1

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

A2

Experimental group

Description:

Part A, Parallel design Arm 2

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

A3

Experimental group

Description:

Part A, Parallel design Arm 3

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

A4

Experimental group

Description:

Part A, Parallel design Arm 4

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

A5

Experimental group

Description:

Part A, Parallel design Arm 5

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

A6

Experimental group

Description:

Part A, Parallel design Arm 6

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

A7

Experimental group

Description:

Part A, Parallel design Arm 7

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

A8

Experimental group

Description:

Part A, Parallel design Arm 8

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

A9

Placebo Comparator group

Description:

Part A, Parallel design Arm 9

Treatment:

Drug: Placebo capsules

Drug: Placebo capsules

B1-1

Experimental group

Description:

Part B, Cross-over design, Arm 1

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

B1-2

Experimental group

Description:

Part B, Cross-over design, Arm 2

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

B2-1

Experimental group

Description:

Part B, Cross-over design, Arm 3

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

B2-2

Experimental group

Description:

Part B, Cross-over design, Arm 4

Treatment:

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

Drug: SLV354 capsules

B3

Placebo Comparator group

Description:

Part B, Cross-over design, Arm 5

Treatment:

Drug: Placebo capsules

Drug: Placebo capsules