Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects

NCT00948662 | Completed Phase 1

• 2 other identifiers: 3276A1-1000B2081001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult subjects.

Conditions

Healthy

Keywords

Safety; tolerability; ascending single doses; healthy subjects

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability.

  5 days

Secondary Outcomes (4)

• Maximum concentration (Cmax) for PF-05212377 over time.

  5 days

• Measurement of Area Under the curve (AUC) for PF-05212377.

  5 days

• Time of maximum (Tmax) concentration of PF-05212377 in plasma.

  5 days

• Elimination half life (t1/2) of PF-05212377.

  5 days

Study Arms (3)

1

EXPERIMENTAL

active arm/healthy young

Drug: SAM-760

2

PLACEBO COMPARATOR

placebo arm

Drug: Placebo of SAM-760

3

OTHER

ketoconazole interaction evaluation

Drug: ketoconazole

Interventions

SAM-760 DRUG

SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day

1

Placebo of SAM-760 DRUG

SAM-760 matching placebo capsule, single dose, 1 day,

Also known as: Placebo

2

ketoconazole DRUG

Ketoconazole oral tablets, 200 mg bid, 14 days

Also known as: ketoconazole interaction arm

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women of non-childbearing potential aged 18 to 50 years inclusive (healthy young subjects) and \> 65 years (healthy elderly subjects) at screening.
• Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight \>= 50 kg.

You may not qualify if:

• Presence or history of any disorder that may prevent the successful completion of the study.
• Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational drug or placebo.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Rueil-Malmaison, France, 92502, France

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

SAM-760; Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

FR (1)