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

NCT01929629 | Completed Phase 1

• 1 other identifier: D4930C00001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gonococcal (GC) Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (8)

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

  Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose

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

  Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose

• 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)]

  Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose

• 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)]

  Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose

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

  Samples taken at predose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose

Study Arms (2)

Placebo fasting

PLACEBO COMPARATOR

Single or multiple dosing placebo

Drug: Part A

Active fed condition

EXPERIMENTAL

AZD0914 given as single dose

Drug: Part B

Interventions

Part A DRUG

Single ascending doses

Placebo fasting

Part B DRUG

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

Active fed condition

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Publications (1)

• 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.

  PMID: 30373802 DERIVED

MeSH Terms

Conditions

Gonorrhea; Infections

Interventions

Medicare Part B

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Medicare; Medical Assistance; Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations; Insurance, Health; Insurance; Legislation as Topic; Social Control, Formal

Study Officials

• David Mathews, MD

  Quintiles Phase I unit, Kansas

  PRINCIPAL INVESTIGATOR

• Humphrey Gardener, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 28, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

US (1)