NCT00827489
Terminated
Phase 1
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTC-867 Administered Orally to Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 sites72 target enrollmentJanuary 2009
Overview
- Phase
- Phase 1
- Intervention
- HTC-867
- Conditions
- Healthy Subjects
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 72
- Primary Endpoint
- Safety as measured by the number of adverse events and serious adverse events. Tolerability as measured by occurrence of dose limiting toxicities.
- Status
- Terminated
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
HTC-867
Intervention: HTC-867
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Safety as measured by the number of adverse events and serious adverse events. Tolerability as measured by occurrence of dose limiting toxicities.
Time Frame: 5 months
Secondary Outcomes
- Pharmacokinetic and pharmacodynamic parameters.(5 months)
Similar Trials
Withdrawn
Phase 1
Study Evaluating Single Doses of GAP-134Healthy SubjectsNCT00820521Wyeth is now a wholly owned subsidiary of Pfizer
Completed
Phase 1
Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing PotentialFibroidNCT00427544Wyeth is now a wholly owned subsidiary of Pfizer
Completed
Phase 1
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese FemalesUterine Leiomyomata (Fibroids)NCT00444704Wyeth is now a wholly owned subsidiary of Pfizer
Completed
Phase 1
Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257Healthy SubjectsNCT00722501Wyeth is now a wholly owned subsidiary of Pfizer48
Completed
Phase 1
Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy SubjectsHealthyNCT00550381Wyeth is now a wholly owned subsidiary of Pfizer72