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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Gonococcal (GC) Infection

Treatments

Drug: Part B

Drug: Part A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01929629

D4930C00001

Details and patient eligibility

About

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

Full description

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

Enrollment

100 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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