Study Evaluating HTC-867 in Healthy Young and Elderly Subjects

NCT00827489 | Terminated Phase 1

• 1 other identifier: 3253A1-1000
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and tolerability of ascending single oral doses of HTC-867 in healthy young and elderly subjects. This study will also evaluate the way the drug enters and leaves the blood and tissues over time and how the drug acts on and in the body in a fasted and fed state.

Conditions

Healthy Subjects

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (1)

• Safety as measured by the number of adverse events and serious adverse events. Tolerability as measured by occurrence of dose limiting toxicities.

  5 months

Secondary Outcomes (1)

• Pharmacokinetic and pharmacodynamic parameters.

  5 months

Study Arms (2)

HTC-867

EXPERIMENTAL

Drug: HTC-867

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

HTC-867 DRUG

HTC-867

Placebo OTHER

Placebo

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 nonchildbearing potential (WONCBP) aged 18 to 50 years or 65 or greater inclusive at screening.
• WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle-stimulating hormone \[FSH\] ≥38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of study drug.
• Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan.
• Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after study drug administration.
• Healthy as determined by the investigator on the basis of screening evaluations.

You may not qualify if:

• Presence or history of any disorder that may prevent the successful completion of the study.
• History of cardiac disorders (other than hypertension) including but not limited to valvular disease, congestive heart failure, angina pectoris, myocardial infarction, or arrhythmia.
• History of vertigo.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 2, 2009

Record last verified: 2009-09

Locations

US (1)