AZD2115 Multiple Ascending Dose Study

NCT01445782 | Completed Phase 1

• 2 other identifiers: D3060C00002Eudract number 2011-002402-75
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Safety; tolerability; healthy; inhaled

Outcome Measures

Primary Outcomes (1)

• Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), lung function (Spirometry), physical examination, safety labs

  No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis

  baseline, up to 30 days

Secondary Outcomes (4)

• 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

  day 1

• 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))

  day 17

• Description of achievement of plasma drug concentration steady state

  PK samples collected pre-dose on day 1, day 4, day 6, day 10, day 14, day 17

• 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

  day 1, day 17

Study Arms (2)

1

EXPERIMENTAL

AZD2115

Drug: AZD2115

2

PLACEBO COMPARATOR

Placebo to AZD2115

Drug: Placebo

Interventions

AZD2115 DRUG

Multiple dose, oral inhalation (nebuliser solution)

1

Placebo DRUG

Multiple dose, oral inhalation (nebuliser solution)

2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, UK, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: September 27, 2011
• First Posted: October 4, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 8, 2012

Record last verified: 2012-10

Locations

GB (1)