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AZD8075 Single Ascending Dose Study

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ClinicalTrials.gov Identifier: NCT00787072
Recruitment Status : Terminated (After reports of turbidity in urine in 4 of 8 volunteers in the 4th cohort, the study was halted temporarily.)
First Posted : November 7, 2008
Last Update Posted : December 2, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: AZD8075 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD8075 in Healthy Male Volunteers
Study Start Date : October 2008
Primary Completion Date : January 2009
Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: 1 Drug: AZD8075
Single dose, the starting dose will be 7 mg, oral suspension, with up to 8 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits.
Placebo Comparator: 2 Drug: Placebo
Oral suspension



Primary Outcome Measures :
  1. Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ]

Secondary Outcome Measures :
  1. PK variables [ Time Frame: Frequent sampling occasions during study days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed, written and dated informed consent prior to any study specific procedures.
  • 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:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787072


Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Pettersson AstraZeneca R&D, Lund, Sweden
Principal Investigator: Wolfgang Kühn Quintiles, Uppsala, Sweden

Responsible Party: Christer Hultquist, Medical Science Director, AstraZeneca R&D Lund, Sweden
ClinicalTrials.gov Identifier: NCT00787072     History of Changes
Other Study ID Numbers: D3801C00001
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: November 2010