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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo for Naproxen; Drug: Naproxen; Drug: Placebo for AZD1386; Drug: AZD1386

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945178

EudraCT No.: 2009-012114-43

D5090C00021

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 4 patient groups

Part A: A

Experimental group

Description:

AZD1386

Treatment:

Drug: AZD1386

Part A: B

Experimental group

Description:

Placebo for AZD1386

Treatment:

Drug: Placebo for AZD1386

Part B: A

Experimental group

Description:

Naproxen

Treatment:

Drug: Naproxen

Part B: B

Experimental group

Description:

Placebo for Naproxen

Treatment:

Drug: Placebo for Naproxen