Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Naproxen

Criteria

Inclusion Criteria:

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

• Healthy male and female (of non childbearing potential)

• Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and a weight of ≥50 to ≤100 kg

Exclusion Criteria:

• History or presence of any clinically significant disease or disorder in the opinion of the investigator.

• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.