Healthy SubjectsPhase 1NCT00827489
Study Evaluating HTC-867 in Healthy Young and Elderly Subjects
A Phase 1 study testing HTC-867 in people with Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- HTC-867
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- The elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination findings, vital sign measurements, 12-lead electrocardiograms (ECGs), or clinical laboratory test results that are associated with stable, chronic, and well-controlled medical conditions, so long as those deviations do not meet the stated specific criteria for exclusion
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTC-867 Administered Orally to Healthy Subjects
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
- Being tested
- HTC-867, Placebo
- Keywords
- schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTC-867Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| HTC-867 | Experimental | Not described Receives: Drug: HTC-867 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by the number of adverse events and serious adverse events. Tolerability as measured by occurrence of dose limiting toxicities.
Measured: 5 months
Secondary outcomes (1)
Pharmacokinetic and pharmacodynamic parameters.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827489
- Sponsor's protocol ID
- 3253A1-1000
- Status last verified
- Sep 2009
- First submitted
- 21 Jan 2009
- Last updated
- 2 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTC-867 Administered Orally to Healthy Subjects
- ClinicalTrials.gov ID
- NCT00827489
- Acronym / sponsor ID
- 3253A1-1000
- Conditions
- Healthy Subjects
- Keywords
- schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTC-867 | Experimental | Drug: HTC-867 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTC-867 | Drug | HTC-867 |
| Placebo | Other | Placebo |
Primary outcome
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
1 secondary outcome
Pharmacokinetic and pharmacodynamic parameters.
Time frame: 5 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HTC-867 in people with Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2009.