Pharmacokinetics in Adolescents (PEAK)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: AZD1981 100 mg twice daily for 61/2 days

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196689

D9830C00021

Details and patient eligibility

About

The purpose of this study is to study pharmacokinetics in adolescents.

Full description

An open, single centre, phase I study in male adolescents with asthma, aged 12 to 17 years, to assess pharmacokinetics of orally administered AZD1981 tablets 100 mg twice daily for 61/2 days.

Enrollment: 21 patients

Sex: Male

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent prior to any study specific procedures
• A minimum of 6 months documented history of asthma
• Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1 (pre-entry)

Exclusion criteria

• Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate
• Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the patient at risk because of his participation in the study

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

1

Experimental group

Description:

AZD1981 100 mg twice daily for 6 ½ days

Treatment:

Drug: AZD1981 100 mg twice daily for 61/2 days