HealthyPhase 1NCT00694044
Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects
A Phase 1 study testing varenicline in people with Healthy and Non-Smoking, run by Pfizer at 2 sites in United States.
Trial summary
1. Characterize the tolerability and safety of repeated doses of varenicline in healthy non-smoking elderly subjects. 2. Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly subjects. 3. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Non-Smoking
- What is being tested?
- varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Jun 2008
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy, Elderly (65-85 years inclusive), Non-smoker
Who cannot join
- Creatinine Clearnace < 30 ml/min, Evidence or history of clinically significant, unstable diseases
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Miami, Florida, 33169
Pfizer Investigational Site
Orlando, Florida, 32809
About this study
Official title: A Randomized, Investigator and Subject Blind, Sponsor Open Parallel Group Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pro-Cognitive Effects of Varenicline, Under Various Titration Schemes, in Healthy Elderly Non-Smoking Subjects
- Characterize the tolerability and safety of repeated doses of varenicline in healthy non-smoking elderly subjects.
- Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly subjects.
- Evaluate the potential effects of repeat doses of varenicline on cognition in healtly non-smoking elderly subjects.
- Conditions
- Healthy, Non-Smoking
- Being tested
- varenicline, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Champix, Chantix
0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days
vareniclineDrug
Also called Champix, Chantix
0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
vareniclineDrug
Also called Champix, Chantix
0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
PlaceboDrug
Placebo for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Weekly titration | Active comparator | Not described Receives: Drug: varenicline |
| Two Week QD | Active comparator | Not described Receives: Drug: varenicline |
| Two Week BID | Active comparator | Not described Receives: Drug: varenicline |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales)
Measured: 21 days
Steady state pharmacokinetics
Measured: 21 days
Effects on cognition (computerized battery of cognitive tests)
Measured: 21 days
Secondary outcomes (1)
No secondary outcomes.
Measured: Time frame n/a
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694044
- Sponsor's protocol ID
- A3051106
- Status last verified
- Jun 2009
- First submitted
- 5 Jun 2008
- Last updated
- 2 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Investigator and Subject Blind, Sponsor Open Parallel Group Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pro-Cognitive Effects of Varenicline, Under Various Titration Schemes, in Healthy Elderly Non-Smoking Subjects
- ClinicalTrials.gov ID
- NCT00694044
- Acronym / sponsor ID
- A3051106
- Conditions
- Healthy, Non-Smoking
- Keywords
- Safety, Tolerability, Pharmacokinetics, Cognition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Jun 2008 (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.
- Characterize the tolerability and safety of repeated doses of varenicline in healthy non-smoking elderly subjects.
- Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly subjects.
- Evaluate the potential effects of repeat doses of varenicline on cognition in healtly non-smoking elderly subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Weekly titration | Active comparator | Drug: varenicline |
| Two Week QD | Active comparator | Drug: varenicline |
| Two Week BID | Active comparator | Drug: varenicline |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy, Elderly (65-85 years inclusive), Non-smoker
Key exclusion criteria (1 listed)
- Creatinine Clearnace < 30 ml/min, Evidence or history of clinically significant, unstable diseases
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 |
|---|---|---|
| vareniclineAlso: Champix, Chantix0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days | Drug | Weekly titration |
| vareniclineAlso: Champix, Chantix0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days | Drug | Two Week QD |
| vareniclineAlso: Champix, Chantix0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days | Drug | Two Week BID |
| PlaceboPlacebo for 21 days | Drug | Placebo |
Primary outcome
Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales)
Time frame: 21 days
Steady state pharmacokinetics
Time frame: 21 days
Effects on cognition (computerized battery of cognitive tests)
Time frame: 21 days
1 secondary outcome
No secondary outcomes.
Time frame: Time frame n/a
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing varenicline in people with Healthy and Non-Smoking, run by Pfizer at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales) (time frame: 21 days). The study lists 3 primary outcomes in all. 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 Jun 2009.