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

Primary Purpose

Gonococcal (GC) Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Part A

Part B

About this trial

This is an interventional basic science trial for Gonococcal (GC) Infection focused on measuring Phase 1, Healthy Volunteers, First Time in Man, Pharmacokinetics

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo fasting

Active fed condition

Arm Description

Single or multiple dosing placebo

AZD0914 given as single dose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Description of pharmacokinetics(PK) for AZD0914 study part A and B in terms of time to reach maximum observed plasma concentration (tmax)

Description of pharmacokinetics(PK) for AZD0914(Part A and B) in terms of AUC from time zero to time of last quantifiable AZD0914 concentration [AUC(0-last)]

Description of pharmacokinetics(PK) for AZD0914(Part A and B) in terms of AUC from time zero to 24 hours after dosing [AUC(0-24)]

Description of pharmacokinetics(PK) for AZD0914(Part A and B) in terms of terminal half-life (t1/2λz) and apparent plasma clearance (CL/F)

Description of pharmacokinetics(PK) for AZD0914(Part A and B) in terms of apparent terminal phase volume of distribution (Vz/F), and at steady state (Vss/F),mean residence time

Description of pharmacokinetics(PK) for AZD0914 (Part A and B) in terms of cumulative amount of investigation product (IP) excreted unchanged into urine from zero to time t [Ae(0-t)],

Description of pharmacokinetics(PK) for AZD0914 (Part A and B) in terms of fraction of dose excreted unchanged into urine (fe), and renal clearance (CLr)

Full Information

NCT ID

NCT01929629

First Posted

August 23, 2013

Last Updated

April 14, 2014

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01929629

Brief Title

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

Official Title

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

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gonococcal (GC) Infection

Keywords

Phase 1, Healthy Volunteers, First Time in Man, Pharmacokinetics

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo fasting

Arm Type

Placebo Comparator

Arm Description

Single or multiple dosing placebo

Arm Title

Active fed condition

Arm Type

Experimental

Arm Description

AZD0914 given as single dose

Intervention Type

Drug

Intervention Name(s)

Part A

Intervention Description

Single ascending doses

Intervention Type

Drug

Intervention Name(s)

Part B

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Applies to Part A and B

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame