A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults

NCT01707082 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2013-07-31

No results posted yet for this study

Summary

Part A of the study will test the safety, the amount of drug in the body, and effects of the drug in the body after multiple doses. This will be conducted in healthy overweight adults. Part B of the study will test the effects of multiple doses of the investigational drug on the amount of midazolam, an approved drug, in healthy adults.

Conditions

  • Healthy

Interventions

DRUG

PF-06282999

Tablet, 10 mg, every 8 hours, 14 days

DRUG

Placebo

Tablet, 0 mg, every 8 hours, 14 days

DRUG

PF-06282999

Tablet, 30 mg, every 8 hours, 14 days

DRUG

Placebo

Tablet, 0 mg, every 8 hours, 14 days

DRUG

PF-06282999

Tablet, 100 mg, every 8 hours, 14 days

DRUG

Placebo

Tablet, 0 mg, every 8 hours, 14 days

DRUG

PF-06282999

Tablet, 250 mg, every 8 hours, 14 days

DRUG

Placebo

Tablet, 0 mg, every 8 hours, 14 days

DRUG

PF-06282999

Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days

DRUG

Placebo

Tablet, 0 mg, every 8 or 12 hours, 14 days

DRUG

midazolam

Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14

DRUG

PF-06282999

Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days

DRUG

midazolam

Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14

DRUG

PF-06282999

Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-05-31
Completion
2013-05-31

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 NCT01707082 on ClinicalTrials.gov