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A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595

Primary Purpose

Healthy Volunteers, Bacterial Infections

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

OP0595

Placebo

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Caucasian males aged between 18 and 45 years (inclusive) at Screening
A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening
Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests
Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1

Exclusion Criteria:

Receipt of any investigational agent or drug within four months before Screening
A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria
Hypersensitivity and/or allergy to drugs
Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders
A history of chronic or recurrent infections or current active infection
A recent history of surgery within three months prior to Screening, determined by the Investigator to be clinically relevant
A history or presence of malignancy
Donation of blood (or loss of blood) greater than 400 ml within three months before Screening
A history of smoking at any time within one year before Screening

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ascending single dose of OP0595

Normal Saline

Arm Description

Outcomes

Primary Outcome Measures

Safety from baseline through the end of the study

Number of patients with adverse events

Secondary Outcome Measures

Plasma PK parameters of OP0595 and its metabolites

Cmax, tmax, AUC0-last, AUC0-inf, Kel, T1/2, CLtot, Vdss

Urine PK parameters of OP0595 and its metabolites

Ae, Ae0-t, Ae0-t/Dose, CLr

Full Information

NCT ID

NCT02134834

First Posted

May 7, 2014

Last Updated

December 11, 2014

Sponsor

Meiji Seika Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02134834

Brief Title

A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595

Official Title

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously in Healthy Male Subjects.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meiji Seika Pharma Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.

6. Conditions and Keywords

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

Healthy Volunteers, Bacterial Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ascending single dose of OP0595

Arm Type

Experimental

Arm Title

Normal Saline

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

OP0595

Intervention Description

Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Primary Outcome Measure Information:

Title

Safety from baseline through the end of the study

Description

Number of patients with adverse events

Time Frame

Day 1 to Day 7

Secondary Outcome Measure Information:

Title

Plasma PK parameters of OP0595 and its metabolites

Description

Cmax, tmax, AUC0-last, AUC0-inf, Kel, T1/2, CLtot, Vdss

Time Frame

Day 1 to Day 2

Title

Urine PK parameters of OP0595 and its metabolites

Description

Ae, Ae0-t, Ae0-t/Dose, CLr

Time Frame

Day 1 to Day 2

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Caucasian males aged between 18 and 45 years (inclusive) at Screening A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1 Exclusion Criteria: Receipt of any investigational agent or drug within four months before Screening A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria Hypersensitivity and/or allergy to drugs Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders A history of chronic or recurrent infections or current active infection A recent history of surgery within three months prior to Screening, determined by the Investigator to be clinically relevant A history or presence of malignancy Donation of blood (or loss of blood) greater than 400 ml within three months before Screening A history of smoking at any time within one year before Screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitsuharu Egawa

Organizational Affiliation

Meiji Seika Pharma Co., Ltd.

Official's Role

Study Chair

Facility Information:

City

Perth,

State/Province

Western Australia

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

32041717

Citation

Mallalieu NL, Winter E, Fettner S, Patel K, Zwanziger E, Attley G, Rodriguez I, Kano A, Salama SM, Bentley D, Geretti AM. Safety and Pharmacokinetic Characterization of Nacubactam, a Novel beta-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02229-19. doi: 10.1128/AAC.02229-19. Print 2020 Apr 21.

Results Reference

derived

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A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595

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