A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers

NCT01264250 | Completed Phase 1

• 1 other identifier: D4120C00001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927.

Conditions

Healthy

Keywords

Safety; Tolerability; pharmacokinetics; drug metabolism

Outcome Measures

Primary Outcomes (5)

• Safety and tolerability of AZD2927, at screening

  Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening

• Safety and tolerability of AZD2927, day 1

  Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1.

• Safety and tolerability of AZD2927, day 2

  Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2.

• Safety and tolerability of AZD2927, day 3

  Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3.

• Safety and tolerability of AZD2927, at follow up

  Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up.

Secondary Outcomes (3)

• Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1

  Pharmacokinetic sampling will be performed day 1

• Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2

  Pharmacokinetic sampling will be performed day 2

• Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3

  Pharmacokinetic sampling will be performed day 3

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD2927

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD2927 DRUG

Single dose of AZD2927

1

Placebo DRUG

Single dose of placebo

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Healthy male subjects aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture
• Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the Investigational Product (IP)
• Have a body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight of at least 50.0 kg and no more than 100.0 kg

You may not qualify if:

• History of 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 results or the subject's ability to participate in the study
• History or presence of gastrointestinal, mental, cardiac, hepatic or renal disorder, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Abnormal vital signs, after 10 minutes supine rest
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IP
• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

AZD2927

Study Officials

• Wolfgang Kühn, MD

  Quintiles AB

  PRINCIPAL INVESTIGATOR

• Helen Lunde, MD

  AstraZeneca

  STUDY DIRECTOR

• Mirjana Kujacic, MD

  AstraZeneca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 21, 2010
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 24, 2011

Record last verified: 2011-05

Locations

SE (1)