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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00688831
First received: May 30, 2008
Last updated: December 1, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Healthy
Drug: AZD1305
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • BIM 19-30 kg/m2

Exclusion Criteria:

  • Potassium outside normal reference values
  • ECG findings outside normal range
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688831

Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: Helen Lunde, MD, Medical Science Director, Emerging Arrythmias & Lipids, AstraZeneca
ClinicalTrials.gov Identifier: NCT00688831     History of Changes
Other Study ID Numbers: D3190C00002
Study First Received: May 30, 2008
Last Updated: December 1, 2010
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
AZD1305
SAD
safety
pharmcokinetics
Safety and tolerability

ClinicalTrials.gov processed this record on October 21, 2014