14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: SLV337 suspension; Drug: SLV337 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01176201

S337.1.005

2010-020006-15 (EudraCT Number)

Details and patient eligibility

About

This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.

Full description

The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• BMI 18 - 28 kg/m2
• SBP 90-140
• DBP 50-90

Exclusion Criteria

• Seizures,
• Orthostatic hypotension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

A

Experimental group

Description:

400 mg suspension

Treatment:

Drug: SLV337 suspension

B

Active Comparator group

Description:

5 x 200 mg immediate release capsule

Treatment:

Drug: SLV337 capsule