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

NCT01419600 | Completed Phase 1

• 2 other identifiers: D1883C000062011-002412-87
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Phase 1; healthy volunteers; safety; tolerability; pharmacokinetics; single ascending dose study

Outcome Measures

Primary Outcomes (6)

• Evaluate the safety of AZD8683 by assessing the frequency of adverse events

  Adverse events are captured from screening and captured on each clinic day and on the follow up day.

• Evaluate the safety of AZD8683 by assessing a panel of laboratory safety assessments

  Lab safety assessments are taken at screening, pre-dose on day 1 and then 24 hours, and 48 hours post-dose and again on follow up.

• Evaluate the safety of AZD8683 by assessing dECG.

  dECG is conducted pre-dose and then 15 minutes, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 4 hours, 8 hours 12 hours, 24 hours and 48 hours post dose.

• Evaluate the safety of AZD8683 by assessing physical examination

  A physical examination is conducted at screening, day -1, day 3 and again at follow-up.

• Evaluate the safety of AZD8683 by assessing vital signs (BP and pulse)

  Vital signs are measured at screening, pre-dose and then 15 minutes, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours and 48 hours post dose

• Evaluate the safety of AZD8683 by assessing Spirometry

  Spirometry is conducted pre-dose and at 5 minutes, 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours

Secondary Outcomes (16)

• The maximum plasma concentration (Cmax) will be determined for AZD8683

  pre-dose and than 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours and 120 hours post dose

• The time to Cmax (tmax) will be determined for AZD8683

  pre-dose and then 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours and 120 hours post dose.

• The Terminal half-life (t1/2z)will be determined for the AZD8683

  pre-dose and then 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours and 120 hours post dose.

• Area under the plasma concentration-time curve from zero to 24 h (AUC(0-24))

  pre-dose and than 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours post dose

• Area under the plasma concentration-time curve from zero to 48 h (AUC(0-48)

  0 minutes, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours post dose

Study Arms (2)

Group 1 - 4, single ascending dose AZD 8683

EXPERIMENTAL

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

Drug: AZD8683

Group 1-4 single ascending dose Placebo

PLACEBO COMPARATOR

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

Drug: Placebo to match

Interventions

AZD8683 DRUG

Single Dose Inhaled IMP via Turbuhaler

Group 1 - 4, single ascending dose AZD 8683

Placebo to match DRUG

Single dose Inhaled Placebo via Turbuhaler

Group 1-4 single ascending dose Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures Healthy male subjects aged 18
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, UK, United Kingdom

Location

Study Officials

• Carin Jorup

  AstraZeneca

  STUDY DIRECTOR

• Darren Wilbraham

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 18, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 3, 2012

Record last verified: 2012-07

Locations

GB (1)