---
title: Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects
nct_id: NCT01757756
overall_status: COMPLETED
phase: PHASE1
sponsor: Pfizer
study_type: INTERVENTIONAL
primary_condition: Diabetes Mellitus
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01757756.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01757756"
ct_last_update_post_date: 2012-12-31
last_seen_at: "2026-05-12T06:23:00.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects

**Official Title:** A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 In Otherwise Healthy Overweight And Obese Subjects

**NCT ID:** [NCT01757756](https://clinicaltrials.gov/study/NCT01757756)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 12
- **Lead Sponsor:** Pfizer
- **Conditions:** Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
- **Start Date:** 2012-10
- **Completion Date:** 2012-11
- **CT.gov Last Update:** 2012-12-31

## Brief Summary

This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of Pf-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Evidence or history of any chronic ongoing or current pulmonary disease.
* History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
```

## Arms

- **Arm Label Pf-05175157, placebo, midazolam** (EXPERIMENTAL)

## Interventions

- **Pf-05175157** (DRUG) — 200-mg administered twice daily for 14 days
- **placebo** (DRUG) — placebo administered twice daily for 14 days
- **midazolam** (DRUG) — midazolam 3-mg admistered as single doses on Day 0 and Day 11.

## Primary Outcomes

- **Maximum Observed Plasma Concentration (Cmax)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose)_
- **Area Under the Curve from Time Zero to end of dosing interval (AUCtau)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose)_
- **Time to Reach Maximum Observed Plasma Concentration (Tmax)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose)_
- **Maximum Observed Plasma Concentration (Cmax)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose)_
- **Time to Reach Maximum Observed Plasma Concentration (Tmax)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose)_
- **Area Under the Curve from Time Zero to end of dosing interval (AUCtau)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose)_
- **Plasma Decay Half-Life (t1/2)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose)_
- **Apparent Volume of Distribution (Vz/F)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose)_
- **Apparent Oral Clearance (CL/F)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose)_
- **Accumulation Ratio (Rac)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours postdose)_
- **Ae,tau** _(time frame: 0-12 hr)_
- **Ae%** _(time frame: 0-12 hr)_
- **Clr** _(time frame: 0-12 hr)_
- **Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours)_
- **Maximum Observed Plasma Concentration (Cmax)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours)_
- **Time to Reach Maximum Observed Plasma Concentration (Tmax)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours)_
- **Plasma Decay Half-Life (t1/2)** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours)_
- **Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]** _(time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours)_
- **fasting triglycerides** _(time frame: 14 days)_
- **fasting LDL-cholesterol** _(time frame: 14 days)_
- **fasting total cholesterol** _(time frame: 14 days)_
- **fasting HDL cholesterol** _(time frame: 14 days)_

## Locations (1)

- Pfizer Investigational Site, South Miami, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pfizer investigational site|south miami|florida|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01757756.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01757756*  
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