A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914

Phase 1CompletedNCT01929629

AstraZeneca100 enrolled

Overview

The purpose of this study is to assess the safety and tolerability of orally administered AZD0914 in healthy adult subjects.

A Phase I, Randomized, Placebo-controlled, Single-center Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0914 After a Single Oral Administration and to Assess the Effect of Food in Healthy Adult Volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

100

Conditions

Gonococcal (GC) Infection

Interventions

Part ADRUG

Single ascending doses

Part BDRUG

Single doses food effect. Subjects to receive 2 single doses, one in fed and one in fasted.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female (of non-childbearing potential)subjects aged 18 to55 years (inclusive). * Have a body mass index (BMI) between 18.00 and 30.50 kg/m2 and weigh at least 50 kg and no more than 100 kg * Male subjects should be willing to use barrier contraception, ie, condoms, from the day of dose administration until at least 3 months after dose administration of the IP Exclusion Criteria: * History of any important clinically significant disease or disorder which, in the opinion of the PI, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks from the first administration of IP as judged by the PI * History of gastrointestinal ulcer disease, inflammatory bowel disease, indigestion symptoms \>3 times a week, or blood in stool in previous 6 months not related to anal trauma

Locations (1)

Research Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Description of the safety profile in terms of adverse events; blood pressure, heart rate and body temperature; electrocardiograms; telemetry; clinical chemistry ; haematology and physical examination

Applies to Part A and B

Time frame: From admission on day -1 until follow up. ( Max 16 days)

Secondary Outcomes

Description of pharmacokinetics(PK) for AZD0914 study part A and B in terms of maximum observed plasma concentration (Cmax)