Multiple Dose Tolerance Study For PF-04958242
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01238679
First received: November 2, 2010
Last updated: April 11, 2012
Last verified: April 2012
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Purpose
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered for 14 days in healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-04958242 0.03 mg Drug: PF-04958242 0.05 mg Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase I, Randomized, Subject And Investigator-Blind, Sponsor Open, Multiple Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Healthy Adult Volunteers |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Composite of PF-04958242 Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1 [ Time Frame: Day 1-2 ] [ Designated as safety issue: No ]
- Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
- Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
- Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14 [ Time Frame: Day 14-18 ] [ Designated as safety issue: No ]
- Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14 [ Time Frame: Day 14-15 ] [ Designated as safety issue: No ]
- Sheehan Suicidality Tracking Scale [ Time Frame: Days 0, 14, 24 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Drug Liking Questionaire [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
- Digit symbol substitution test [ Time Frame: Days 0, 14 ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | November 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-04958242 |
Drug: PF-04958242 0.03 mg
0.03 mg dose tablet every 12 hours for 14 days
Drug: PF-04958242 0.05 mg
PF-04958242 0.05 mg dose tablet every 24 hours for 14 days
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo tablet every 12 hours or every 24 hours for 14 days
|
Detailed Description:
A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- males or females of non-childbearing capacity
Exclusion Criteria:
- No medical, neurological or psychiatric illness
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01238679 History of Changes |
| Other Study ID Numbers: | B1701002 |
| Study First Received: | November 2, 2010 |
| Last Updated: | April 11, 2012 |
| Health Authority: | Singapore: Health Sciences Authority |
Keywords provided by Pfizer:
|
safety tolerability pharmacokinetics healthy volunteers |
ClinicalTrials.gov processed this record on May 22, 2013