Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers
NCT02309827
Last updated date
ABOUT THIS STUDY
This study is a first in human study of PF-06651600. PF-06651600 is being developed for
treatment of inflammatory bowel disease. This study will test single and multiple doses of
PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics
and pharmacodynamics of PF-06651600 in healthy volunteers.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
- BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of personally signed and dated informed consent document.
- Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
- Subjects must avoid high intensity UV light exposure (eg, active sunbathing, tanning beds/booths or sunlamps) from the first dose of study drug and for the duration of the study.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21
drinks/week for males.
- Screening blood pressure >140/90 mm Hg.
- Screening laboratory abnormalities as defined by the protocol.
- Unwilling or unable to comply with the Lifestyle Guidelines as defined by the
protocol.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers | |||
| Official Title ICMJE | A Phase 1, Randomized, Double Blind, Third-party Open, Placebo-controlled, Single And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06651600 In Healthy Subjects | |||
| Brief Summary | This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 in healthy volunteers. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
| Condition ICMJE | Healthy | |||
| Intervention ICMJE | Drug: PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort. | |||
| Study Arms ICMJE |
| |||
| Publications * | Telliez JB, Dowty ME, Wang L, Jussif J, Lin T, Li L, Moy E, Balbo P, Li W, Zhao Y, Crouse K, Dickinson C, Symanowicz P, Hegen M, Banker ME, Vincent F, Unwalla R, Liang S, Gilbert AM, Brown MF, Hayward M, Montgomery J, Yang X, Bauman J, Trujillo JI, Casimiro-Garcia A, Vajdos FF, Leung L, Geoghegan KF, Quazi A, Xuan D, Jones L, Hett E, Wright K, Clark JD, Thorarensen A. Discovery of a JAK3-Selective Inhibitor: Functional Differentiation of JAK3-Selective Inhibition over pan-JAK or JAK1-Selective Inhibition. ACS Chem Biol. 2016 Dec 16;11(12):3442-3451. Epub 2016 Nov 10. | |||
* 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 | 80 | |||
| Original Estimated Enrollment ICMJE | 56 | |||
| Actual Study Completion Date ICMJE | April 2016 | |||
| Actual Primary Completion Date | April 2016 (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 | NCT02309827 | |||
| Other Study ID Numbers ICMJE | B7981001 2014-004326-17 ( EudraCT Number ) PF-06651600 ( Other Identifier: Alias Study Number ) JAK3 ( Other Identifier: Alias Study 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 | September 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||