To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Inhaled AZD8683

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo to match; Drug: AZD8683

Study type: Interventional

Funder types: Industry

Identifiers

NCT01419600

2011-002412-87 (EudraCT Number)

D1883C00006

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing single doses of AZD8683 administered via inhalation

Full description

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of inhaled AZD8683 after Single Ascending Doses administered via Turbuhaler in Healthy Subjects

Enrollment: 38 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures Healthy male subjects aged 18
• 45 years with suitable veins for cannulation or repeated venepuncture
• Male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product
• Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive

Exclusion criteria

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

• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product

• Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:

  • Systolic blood pressure >140 mm Hg
  • Diastolic blood pressure >90 mm Hg
  • Heart rate <40 or >85 beats per minute Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG. This includes subjects with any of the following:
  • PR(PQ) interval prolongation >200 ms or dropped beats (single non conducted P-waves) based on screening or Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Group 1 - 4, single ascending dose AZD 8683

Experimental group

Description:

Subjects will participate in 1 of 4 groups. In each group, 6 subjects will receive AZD8683 and 2 subjects will receive placebo.

Treatment:

Drug: AZD8683

Group 1-4 single ascending dose Placebo

Placebo Comparator group

Description:

Subjects will participate in 1 of 4 groups. In each group, 6 subjects will receive AZD8683 and 2 subjects will receive placebo.

Treatment:

Drug: Placebo to match