Drug Interaction Study Between AZD3480 and Cytochrome P450 (Cocktail)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Metabolism; Alzheimer's Disease

Treatments: Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin); Drug: Placebo; Drug: AZD3480

Study type: Interventional

Funder types: Industry

Identifiers

NCT00692510

EudraCt nr 2007-002456-10

D3690C00016

Details and patient eligibility

About

The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity.

Enrollment: 18 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed written informed consent
• Clinically normal physical findings and laboratory values

Exclusion criteria

• Clinically significant illness or clinically relevant trauma within three weeks before the first dose
• History of clinically significant disease
• Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

AZD3480 + cocktail

Treatment:

Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)

Drug: AZD3480

2

Placebo Comparator group

Description:

Placebo + cocktail

Treatment:

Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)

Drug: Placebo