---
title: Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects.
nct_id: NCT00536497
overall_status: WITHDRAWN
phase: PHASE1
sponsor: GlaxoSmithKline
study_type: INTERVENTIONAL
primary_condition: Healthy Subjects
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00536497.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00536497"
ct_last_update_post_date: 2015-02-16
last_seen_at: "2026-05-12T06:54:08.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects.

**Official Title:** A 2 Part Open-label, Randomised, Crossover Study to Compare the Effects of Formulation, Food and Particle Size on the Pharmacokinetic Profiles of a Single 175mg Dose of GW842166X in Healthy Male and Female Volunteers

**NCT ID:** [NCT00536497](https://clinicaltrials.gov/study/NCT00536497)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** Compound terminated
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** GlaxoSmithKline
- **Conditions:** Healthy Subjects
- **Start Date:** 2007-09
- **CT.gov Last Update:** 2015-02-16

## Brief Summary

GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical development as a novel oral treatment for inflammatory pain. The purpose of the study is to compare the effects of formulation, food and particle size on the pharmacokinetic profiles of a single 175mg dose of GW842166X in healthy male and female volunteers.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Body weight \>50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive.
* Healthy as judged by a responsible physician.

Exclusion Criteria:

* Positive pre-study urine screen for drugs of abuse or alcohol breath test.
```

## Interventions

- **GW842166X** (DRUG)

## Primary Outcomes

- **Plasma GW842166 Cmax and AUC (O-Infinity)** _(time frame: Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose))_

## Secondary Outcomes

- **Plasma GW842166 AUC (0-t), tlag,tmax and t1/2** _(time frame: Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose))_

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — 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)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00536497.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00536497*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*