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AZD2115 Multiple Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01445782
First received: September 27, 2011
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

This study will investigate the safety and tolerability of AZD2115 following administration of multiple ascending doses.


Condition Intervention Phase
Healthy
 Drug: AZD2115
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD2115 in Healthy Male Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), lung function (Spirometry), physical examination, safety labs [ Time Frame: baseline, up to 30 days ] [ Designated as safety issue: Yes ]
    No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis


Secondary Outcome Measures:
  • Description of the pharmacokinetics (PK) of AZD2115 in terms of area under the curve over the time (AUC) and maximum concentration (Cmax) and terminal half-life [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    PK samples collected post-dose at 5mins, 20mins, 40mins, 1hr, 1.5hrs, 2 hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs 36 hrs, 48hrs

  • Description of pharmacokinetics (PK) of AZD2115 in terms of Cmax, area under the plasma concentration-time curve from zero to the end of the dosing interval (AUC(0-τ)) [ Time Frame: day 17 ] [ Designated as safety issue: No ]
    PK samples collected post-dose at 5mins, 20mins, 40mins, 1hr, 1.5hrs, 2 hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs 36 hrs, 48hrs 72hrs, 96hrs, 120hrs and 168hrs.

  • Description of achievement of plasma drug concentration steady state [ Time Frame: PK samples collected pre-dose on day 1, day 4, day 6, day 10, day 14, day 17 ] [ Designated as safety issue: No ]
    An exploratory analysis of achievement of steady state will be evaluated graphically.

  • Description of pharmacodynamics of AZD2115 in terms of FEV1 (forced expiratory volume in the first second), FVC (forced vital capacity), potassium, glucose, systolic and diastolic blood pressure, pulse rate, heart rate, QTcF [ Time Frame: day 1, day 17 ] [ Designated as safety issue: No ]
    QTcF defined as QT interval corrected for heart rate using Fridericia's formula


Enrollment: 32
Study Start Date: October 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD2115
 Drug: AZD2115
Multiple dose, oral inhalation (nebuliser solution)
Placebo Comparator: 2
Placebo to AZD2115
 Drug: Placebo
Multiple dose, oral inhalation (nebuliser solution)

Detailed Description:

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD2115 in Healthy Male Subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects aged 18 to 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 first administration of the AZD2115 until 3 months after administration and must not donate sperm for 3 months after follow-up
  • Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

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

    • Systolic BP >140 mmHg
    • Diastolic BP >90 mmHg
    • Heart rate <40 or >85 bpm
  • Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
  • Serum potassium concentration of < 3.80 mmol/L on admission (Day -1)
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with the same class to AZD2115 or to excipients
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445782

Locations
United Kingdom
Research Site
London, UK, United Kingdom
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01445782     History of Changes
Other Study ID Numbers: D3060C00002, Eudract number 2011-002402-75
Study First Received: September 27, 2011
Last Updated: October 5, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Safety
tolerability
healthy
inhaled

ClinicalTrials.gov processed this record on May 22, 2013