AZD0914 Phase 1 ADME Study in Healthy Volunteers

NCT ID: NCT02298920

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-02-28

Brief Summary

This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six male healthy volunteers.

Detailed Description

This is an open-label, single dose study in 6 healthy male subjects aged 18 to 55 years. Each subject will be admitted to the clinical pharmacology unit on the day prior to dosing Check in (Day -1) and will remain in the clinical pharmacology unit until up to at least target Day 8 (168 hours post-dose).

All subjects will receive 3000 mg AZD0914 incorporating 18.5 MBq (500 Ci) of [14C] administered as a single oral dose following at least an 8 hour fast from food. Subjects can have water. For specific food and water restrictions.

This study will investigate the metabolic fate and routes of excretion of AZD0914.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single Group

Open Label ADME Study

Group Type: EXPERIMENTAL

AZD0914

Intervention Type: DRUG

Radiolabelled AZD0914 for study of absorption, disposition, metabolism, and excretion in healthy volunteers.

Interventions

AZD0914

Radiolabelled AZD0914 for study of absorption, disposition, metabolism, and excretion in healthy volunteers.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male subjects between 18 and 55 years of age, inclusive, at the time of consent with suitable veins for cannulation or repeated venipuncture;

2. Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements;

3. Within body mass index (BMI) range 19 to 30 kg/m2, inclusive, at screening;

4. Non-smokers in past 6 months;

5. In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs as judged by the Investigator;

Exclusion Criteria

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, interfere with absorption, distribution, metabolism or excretion of drugs, or influence the results or the subject's ability to participate in the study;

2. Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QT interval corrected for heart rate (QTc) changes;

3. Any clinically significant abnormalities in clinical chemistry, hematology, or UA results as judged by the Investigator;

4. Abnormal vital signs, after 10 minutes supine rest, confirmed by repeat, defined as any of the following: systolic blood pressure <90 mmHg or >140 mmHg; diastolic blood pressure <50 mmHg or >90 mmHg; or heart rate <40 or >100 beats per minute;

5. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP;

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

Sponsors

Entasis Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene Mirkin, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit

Locations

Covance Clinical Research Unit

Madison, Wisconsin, United States

Research Site

Madison, Wisconsin, 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

D4930C00003

Identifier Type: -

Identifier Source: org_study_id