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

NCT ID: NCT01929629

Last Updated: 2014-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-03-31

Brief Summary

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

Detailed 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

Conditions

Gonococcal (GC) Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo fasting

Single or multiple dosing placebo

Group Type: PLACEBO_COMPARATOR

Part A

Intervention Type: DRUG

Single ascending doses

Active fed condition

AZD0914 given as single dose

Group Type: EXPERIMENTAL

Part B

Intervention Type: DRUG

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

Interventions

Part A

Single ascending doses

Intervention Type: DRUG

Part B

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Mathews, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles Phase I unit, Kansas

Humphrey Gardener, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Overland Park, Kansas, United States

Countries

United States

References

O'Donnell J, Lawrence K, Vishwanathan K, Hosagrahara V, Mueller JP. Single-Dose Pharmacokinetics, Excretion, and Metabolism of Zoliflodacin, a Novel Spiropyrimidinetrione Antibiotic, in Healthy Volunteers. Antimicrob Agents Chemother. 2018 Dec 21;63(1):e01808-18. doi: 10.1128/AAC.01808-18. Print 2019 Jan.

Reference Type: DERIVED

PMID: 30373802 (View on PubMed)

Other Identifiers

D4930C00001

Identifier Type: -

Identifier Source: org_study_id