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CompletedNCT00799331Updated Jun 9, 2009

Exploratory Study to Assess the Pharmacokinetics of AZD5985

A Phase 1 interventional study of AZD5985 and placebo in Healthy, sponsored by AstraZeneca. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-06-09.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers

02

Conditions studied

  • Healthy

Keywords

  • Healthy volunteers
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Provision of signed, written and dated informed consent prior to any study specific procedures.
  • Healthy male subjects aged 18 to 45 years (inclusive).
  • Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
  • Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.

Exclusion criteria

Exclusion Criteria:

  • History or presence of any clinically significant disease or disorder in the opinion of the investigator.
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
  • Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    A

    AZD5985

    Drug: AZD5985

  • Experimental
    B

    placebo

    Drug: placebo

Interventions

  • DrugAZD5985

    Oral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits.

  • Drugplacebo

    Oral suspension.

06

What researchers measure

Primary outcomes

  1. It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985.

    Time frame: Frequent sampling occasions during study days

07

Study locations

1 site
  • Research Site
    Berlin, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00799331
Lead sponsor
AstraZeneca
First posted
Nov 27, 2008
Start date
Nov 2008
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Jun 9, 2009

Study contacts

Eva Pettersson
study director · AstraZeneca R&D, Lund, Sweden
Maura Fallon
principal investigator · Parexel, Berlin, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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