A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects
NCT02316756
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Healthy male and/or female subjects of non childbearing potential
- BMI of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
- Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drg allergies, but excluding untreated asymptomatic,
seasonal allergies at the time of dosing);
- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half-lives preceding the first dose of study medication (whichever
is longer)
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgement of the investigator, would make the subject
inappropriate for entry into this study.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- San Antonio, Texas
- New Haven, Connecticut
- Isumi-city, Chiba
- Matsuyama-city, Ehime
- Itoshima, Fukuoka
- Kasuga, Fukuoka
- Sapporo-city, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Kuwana, Mie
- Kurashiki, Okayama
- Okayama-city, Okayama
- Toyonaka, Osaka
- Kumagaya-city, Saitama
- Chiba,
- Fukuoka,
- Fukuoka,
- Fukuoka,
- Fukuoka,
- Funabashi, Chiba
- Isumi-city, Chiba
- Matsuyama-city, Ehime
- Higashi-ku, Fukuoka-city, Fukuoka
- Fukuyama, Hiroshima
- Kure, Hiroshima
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Kikuchi-gun, Kumamoto
- Suzuka, MIE
- Tsu, MIE
- Tsu, MIE
- Kumagaya-city, Saitama
- Kumagaya, Saitama
- Fuchu, Tokyo
- Ota-ku, Tokyo
- Setagaya-ku, Tokyo
- Setagaya-ku, Tokyo
- Tachikawa-shi, Tokyo
- Tama, Tokyo
- Kofu, Yamanashi
- Koushu-shi, Yamanashi
- Tsuru-shi, Yamanashi
- Fukuoka,
- Fukuoka,
- Kumamoto,
- Kumamoto,
- Kumamoto,
- Okayama,
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects | ||||||
Official Title ICMJE | A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled First-in-human Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06648671 After Administration Of Single Ascending Doses To Fasted And Fed Healthy Subjects | ||||||
Brief Summary | This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending doses of PF-06648671 in healthy subjects. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science | ||||||
Condition ICMJE | Healthy Subjects | ||||||
Intervention ICMJE |
| ||||||
Study Arms ICMJE |
| ||||||
Publications * | Ahn JE, Carrieri C, Dela Cruz F, Fullerton T, Hajos-Korcsok E, He P, Kantaridis C, Leurent C, Liu R, Mancuso J, Mendes da Costa L, Qiu R. Pharmacokinetic and Pharmacodynamic Effects of a ?-Secretase Modulator, PF-06648671, on CSF Amyloid-? Peptides in Randomized Phase I Studies. Clin Pharmacol Ther. 2020 Jan;107(1):211-220. doi: 10.1002/cpt.1570. Epub 2019 Sep 11. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 18 | ||||||
Original Estimated Enrollment ICMJE | 24 | ||||||
Actual Study Completion Date ICMJE | March 2015 | ||||||
Actual Primary Completion Date | March 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02316756 | ||||||
Other Study ID Numbers ICMJE | B7991001 2014-004394-17 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | June 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |