NCT01176201

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

3 months

First QC Date

July 20, 2010

Last Update Submit

August 25, 2011

Conditions

Healthy Subjects

Keywords

SLV337DiabetesRelative bioavailabilityADME

Outcome Measures

Primary Outcomes (5)

  • AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2)

    Part 1: 5 days Part 2: 8 days

  • AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2)

    Part 2: 8 days

  • Excretion balance of total 14C-radioactivity (Part 2)

    Part 2: 8 days

  • Total 14C-radioactivity (Part 2)

    Part 2: 8 days

  • Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2)

    Part 2: 8 days

Secondary Outcomes (1)

  • Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2)

    Part 1: 19 days Part 2: 15 days

Study Arms (2)

A

EXPERIMENTAL

400 mg suspension

Drug: SLV337 suspension

B

ACTIVE COMPARATOR

5 x 200 mg immediate release capsule

Drug: SLV337 capsule

Interventions

SLV337 suspensionDRUG

400 mg experimental

A
SLV337 capsuleDRUG

5 x 200 mg immediate release capsule

B

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Seizures,
  • Orthostatic hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 61345

Zuidlaren, 9370 AE, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Anita Vanderlaan

    Abbott Healthcare Products BV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2010

First Posted

August 5, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

NL(1)