AZD2115 Multiple Ascending Dose Study

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: AZD2115

Study type

Interventional

Funder types

Industry

Identifiers

NCT01445782

Eudract number 2011-002402-75

D3060C00002

Details and patient eligibility

About

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

Full 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.

Enrollment

32 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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