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Completed

NCT Number: NCT02316756

A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PF-06648671

Drug

Experimental Pfizer compound which will be dosed as oral suspension

Placebo

Drug

Placebo which will be given as oral suspension

Primary outcomes

  1. Number of participants with AEs and SAEs

    Time frame: 0-6 weeks

    Counts of participants who have TEAEs, defined as newly occuring or worsening after first dose. Relatedness to PF-06648671 will be assessed by the investigator (Yes/No). Participants with multiple occurences of an AE within a category will be counted once within the category

  2. Supine vital sign measurement

    Time frame: 0-6 weeks

    Measurement of blood pressure and pulse rate

  3. Electrocardiogram (ECG)

    Time frame: 0-6 weeks

    Measurement of standard 12-lead ECG, single or triplicate

  4. Number of participants with lab test values of potential clinical importance

    Time frame: 0-6 weeks

    Pre-defined criteria were established for each lab test to identify potential clinical importance

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0-72 hours post dose

  2. Area Under the Curve From Time Zeor to Last Quantifiable Concentration (AUClast)

    Time frame: 0-72 hours post dose

  3. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

    Time frame: 0-72 hours post dose

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0-72 hours post dose

  5. Plasma Decay Half-life (t1/2)

    Time frame: 0-72 hours post dose

  6. Apparent Oral Clearance (CL/F)

    Time frame: 0-72 hours post dose

  7. Apparent Volume of Distribution (Vz/F)

    Time frame: 0-72 hours post dose

  8. Plasma Cmax ratio under fed vs fasted conditions

    Time frame: 0-72 hours post dose

  9. Plasma AUClast ratio under fed vs fasted condition

    Time frame: 0-72 hours post dose

  10. Plasma AUCinf ratio under fed vs fasted conditions

    Time frame: 0-72 hours post dose

  11. Plasma Abeta42 Maximum change from baseline

    Time frame: 0-72 hours post dose

  12. Plasma Abeta42, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)

    Time frame: 0-72 hours post dose

  13. Plasma Abeta42, Time to Reach Maximum Observed Effect (Tmax)

    Time frame: 0-72 hours post-dose

  14. Plasma Abeta40 Maximum change from baseline

    Time frame: 0-72 hours post dose

  15. Plasma Abeta40, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)

    Time frame: 0-72 hours post dose

  16. Plasma Abeta40, Time to Reach Maximum Observed Effect (Tmax)

    Time frame: 0-72 hours post-dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 15, 2014
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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