---
title: AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects
nct_id: NCT00785915
overall_status: COMPLETED
phase: PHASE1
sponsor: AstraZeneca
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00785915.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00785915"
ct_last_update_post_date: 2014-10-13
last_seen_at: "2026-05-12T07:34:37.226Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects

**Official Title:** A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6765 in Healthy Male and Female Japanese and Caucasian Subjects

**NCT ID:** [NCT00785915](https://clinicaltrials.gov/study/NCT00785915)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** AstraZeneca
- **Conditions:** Healthy
- **Start Date:** 2008-11
- **Completion Date:** 2009-03
- **CT.gov Last Update:** 2014-10-13

## Brief Summary

This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Body mass index (BMI): 18 to 27 kg/m 2
* Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening.
* Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.

Exclusion Criteria:

* Clinically relevant disease and/or abnormalities (past or present)
* Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
* Use of any prescription medication within 14 days of Day 1
* Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1
* Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1
```

## Arms

- **1** (EXPERIMENTAL)
- **2** (PLACEBO_COMPARATOR) — given (2 subjects in each ethnic/dose group)

## Interventions

- **AZD6765** (DRUG) — single administration and once daily for 5 days
- **Placebo** (DRUG) — single administration and once daily for 5 days

## Primary Outcomes

- **Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments** _(time frame: During the study)_

## Secondary Outcomes

- **Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine** _(time frame: During residential period)_
- **Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765.** _(time frame: During the study)_

## Locations (2)

- Research Site, Glendale, California, United States
- Research Site, Baltimore, Maryland, 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.research site|glendale|california|united states` — added _(2026-05-12)_
- `locations.research site|baltimore|maryland|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00785915.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00785915*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*