---
title: Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate
nct_id: NCT01199029
overall_status: COMPLETED
phase: PHASE1
sponsor: Pfizer
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01199029.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01199029"
ct_last_update_post_date: 2010-12-16
last_seen_at: "2026-05-12T07:09:37.613Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate

**Official Title:** An Open Label Study Evaluating The Effect Of Single Doses Of Pf-04308515 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects

**NCT ID:** [NCT01199029](https://clinicaltrials.gov/study/NCT01199029)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 18
- **Lead Sponsor:** Pfizer
- **Conditions:** Healthy
- **Start Date:** 2010-08
- **Completion Date:** 2010-09
- **CT.gov Last Update:** 2010-12-16

## Brief Summary

This study will investigate the effect of a single dose of PF-04308515 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test.

## Eligibility

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

```
Inclusion Criteria:

* BMI 17.5 to 30.5 kg/m2 and total body weight \>50 kg

Exclusion Criteria:

* Fasting glucose above the limits of the reference range for healthy individuals
* "No treatment" OGTT indicative of impaired fasting glucose or impaired glucose tolerance
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
```

## Arms

- **(Part 1) 10 mg PF-04308515 (8hrs)** (EXPERIMENTAL)
- **(Part 1) 10 mg PF-04308515 (12hrs)** (EXPERIMENTAL)
- **(Part 1) 5 mg Prednisone** (ACTIVE_COMPARATOR)
- **(Part 2) X mg PF-04308515** (EXPERIMENTAL)
- **(Part 2) Y mg PF-04308515** (EXPERIMENTAL)
- **(Part 2) 5 mg Prednisone** (ACTIVE_COMPARATOR)
- **(Part 2) 20 mg Prednisone** (ACTIVE_COMPARATOR)

## Interventions

- **PF-04308515** (DRUG) — 10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT)
- **PF-04308515** (DRUG) — 10 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test(OGTT)
- **Prednisone** (DRUG) — 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
- **PF-04308515** (DRUG) — X mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
- **PF-04308515** (DRUG) — Y mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
- **Prednisone** (DRUG) — 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
- **Prednisone** (DRUG) — 20 mg (5 mg tablets) predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)

## Primary Outcomes

- **Fold change in AUC (0-4hr) relative to no treatment baseline for plasma glucose, plasma insulin and plasma C-peptide** _(time frame: 4 hours)_

## Secondary Outcomes

- **Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma C-peptide** _(time frame: 3 days)_
- **Safety: adverse events, vital sign measurements, physical examination** _(time frame: 3 days)_
- **Pharmacokinetics: sparse PF-04308515 plasma samples will be collected** _(time frame: 3 days)_

## Locations (1)

- Pfizer Investigational Site, Kalamazoo, Michigan, 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)_
- `outcomes.secondary` — 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|kalamazoo|michigan|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01199029.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01199029*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*