A First Time in Man Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1979 in Healthy Males

• Sponsor: AstraZeneca (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02072993
• Collaborator: (none)
• Enrollment: 116
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 28.9

Study Details

Study Description

Brief Summary

This is a first time in human study to assess the safety and tolerability of AZD1979 following oral administration of single ascending doses in healthy male volunteers. Pharmacokinetics (what the body does to the drug) parameters will also be assessed as secondary objectives.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: AZD1979; Drug: Placebo to match	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral AZD1979 After Single-ascending Doses in Healthy Male Volunteers
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD1979 Single ascending doses of oral solution AZD1979	Drug: AZD1979; Single dose, oral solution administration
Placebo Comparator: Placebo Placebo to match single ascending doses of oral solution AZD1979	Drug: Placebo to match; Single dose, oral solution administration

Outcome Measures

Primary Outcome Measures

1. Safety variables in terms of: Adverse events, clinical laboratory variables, vital signs, electrocardiograms and telemetry, physical examinations, and assessments of anxiety and mood [Up to 62 days]

Secondary Outcome Measures

1. Pharmacokinetics of AZD1979 assessed by means of plasma concentration analyses [up to 48 hours post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

• Healthy male volunteer aged 18 to 50 years

• Have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive

Exclusion Criteria:

• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study

• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs

• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP

• Any clinically important abnormalities in clinical chemistry, endocrine hormones, hematology, or urinalysis results as judged by the Investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Overland Park	Kansas	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: Eleanor Lisbon, MD, Quintiles 6700 W 115th Street, Overland Park, KS USA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02072993
• Other Study ID Numbers: D3930C00001
• First Posted: Feb 27, 2014
• Last Update Posted: Jul 29, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by AstraZeneca: Phase I, healthy, pharmacokinetics

Study Results

No Results Posted as of Jul 29, 2014