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Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects

Primary Purpose

Healthy Volunteers, Bacterial Infections

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

RPX7009

Placebo

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adult males and/or females (of Non Child-bearing potential), 18 to 55 years of age
Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
Medically healthy with clinically insignificant screening results
Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.
Sexually abstinent or use acceptable methods of birth control

Exclusion Criteria:

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
Documented hypersensitivity reaction or anaphylaxis to any medication.
Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
Plasma donation within 7 days prior to Day 1.
Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).

Sites / Locations

CMAX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ascending Single and Multiple dose of RPX7009

Normal Saline

Arm Description

Ascending Single and Multiple dose of RPX7009

Ascending Single and multiple dose of normal saline.

Outcomes

Primary Outcome Measures

Safety from baseline through the end of the study.

Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.

Secondary Outcome Measures

Composite of PK parameters RPX7009 & placebo following single dose administration.

Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.

Full Information

NCT ID

NCT01751269

First Posted

December 13, 2012

Last Updated

July 22, 2013

Sponsor

Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)

1. Study Identification

Unique Protocol Identification Number

NCT01751269

Brief Title

Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects

Official Title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.

Detailed Description

The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents. Rempex is developing a fixed combination antibiotic of a carbapenem plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics of RPX7009, administered alone, in healthy adult subjects.

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

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ascending Single and Multiple dose of RPX7009

Arm Type

Experimental

Arm Description

Ascending Single and Multiple dose of RPX7009

Arm Title

Normal Saline

Arm Type

Placebo Comparator

Arm Description

Ascending Single and multiple dose of normal saline.

Intervention Type

Drug

Intervention Name(s)

RPX7009

Other Intervention Name(s)

(beta-lactamase inhibitor)

Intervention Description

Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal saline

Intervention Description

Ten (10) 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; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.

Time Frame

Study Day 1 to Day 13.

Secondary Outcome Measure Information:

Title

Composite of PK parameters RPX7009 & placebo following single dose administration.

Description

Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.

Time Frame

Study Day 1 to Day 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adult males and/or females (of Non Child-bearing potential), 18 to 55 years of age Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). Medically healthy with clinically insignificant screening results Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1. Sexually abstinent or use acceptable methods of birth control Exclusion Criteria: History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1. Documented hypersensitivity reaction or anaphylaxis to any medication. Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI. Plasma donation within 7 days prior to Day 1. Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jefferey Loutit, MBChB

Organizational Affiliation

Sponsor GmbH

Official's Role

Study Director

Facility Information:

Facility Name

CMAX

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

27527080

Citation

Griffith DC, Loutit JS, Morgan EE, Durso S, Dudley MN. Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of the beta-Lactamase Inhibitor Vaborbactam (RPX7009) in Healthy Adult Subjects. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6326-32. doi: 10.1128/AAC.00568-16. Print 2016 Oct.

Results Reference

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Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects

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