Single Ascending Dose Study (SAD) iv Formulation (2006-006253-27)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688831
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : December 2, 2010
Information provided by:

Brief Summary:
The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body (how it is taken up into the body, distributed around the body and disappears from the body

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD1305 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Ascending Intravenous Doses of AZD1305 in Helahty Male Volunteers
Study Start Date : January 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
Experimental: A
AZD1305 solution for iv infusion
Drug: AZD1305
Solution for iv infusion , single dose

Placebo Comparator: B
NaCl solution for iv infusion
Drug: Placebo
NaCl solution for iv infusion, single dose

Primary Outcome Measures :
  1. Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight [ Time Frame: During the study ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: During all dosing visits ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers
  • BIM 19-30 kg/m2

Exclusion Criteria:

  • Potassium outside normal reference values
  • ECG findings outside normal range

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 identifier (NCT number): NCT00688831

Research Site
Uppsala, Sweden
Sponsors and Collaborators
Study Director: Helen Lunde, MD AstraZeneca R&D Mölndal, Sweden
Principal Investigator: Marianne Hartford, MD, PhD AstraZeneca, Clinical Pharmacology Unit, Sahlgrenska University Hospital, Göeborg, Sweden

Responsible Party: Helen Lunde, MD, Medical Science Director, Emerging Arrythmias & Lipids, AstraZeneca Identifier: NCT00688831     History of Changes
Other Study ID Numbers: D3190C00002
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Safety and tolerability

Additional relevant MeSH terms:
Pharmaceutical Solutions