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A Phase 1 Study To Characterize The Safety, Tolerability, PK And PK Of Repeat Doses Of PF-06648671 In Healthy Adults And Healthy Elderly Subjects

NCT02440100 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2016-11-10

No results posted yet for this study

Summary

This is an investigator-and-subject blind, phase 1 study to characterize the safety, tolerability, pharmacokinetics and central and peripheral pharmacodynamics of 14-day repeated ascending doses of PF-06648671 once a day in healthy adults (part 1) and repeated doses at the maximum tolerated dose (MTD) defined in part 1 in healthy elderly subjects (part 2). The study also include an optional cohort (part 3) to evaluate the drug interaction between PF-06648671 at MTD and CYP3A probe, midazolam

Conditions

  • Healthy Adult Subjects and Healthy Elderly Subjects

Interventions

DRUG

PF-06648671

experimental Pfizer compound which will be dosed as oral suspension, once a day for 14 days

DRUG

Midazolam

commercial available oral solution of 2 mg midazolam as CYP3A probe substrate for drug interaction evaluation. Midazolam will be given as single dose with and without co-administration of PF-06648671

DRUG

Placebo

Matching placebo which will be given as oral suspension, once a day for 14 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02440100 on ClinicalTrials.gov