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Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects

Primary Purpose

Healthy Volunteers, Bacterial Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RPX2003 (Biapenem)

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, 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.
Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. beta-lactam antibiotics such as penicillins, carbapenems, etc).
History of seizures (e.g., epilepsy).
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.
Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1.
Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).

Sites / Locations

Celerion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RPX2003 (Biapenem)

Normal Saline

Arm Description

Single and multiple dose of RPX2003 (Biapenem).

Single and multiple doses 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 RPX2003 & placebo following single dose administration.

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

Composite of PK parameters RPX2003 & placebo following multiple dose administration.

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

Full Information

NCT ID

NCT01702649

First Posted

September 25, 2012

Last Updated

November 29, 2012

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01702649

Brief Title

Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) 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 RPX2003 in Healthy Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (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

RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor 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 (RPX2003 or biapenem) 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 biapenem, 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

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RPX2003 (Biapenem)

Arm Type

Experimental

Arm Description

Single and multiple dose of RPX2003 (Biapenem).

Arm Title

Normal Saline

Arm Type

Placebo Comparator

Arm Description

Single and multiple doses of normal saline.

Intervention Type

Drug

Intervention Name(s)

RPX2003 (Biapenem)

Intervention Description

Six (6) cohorts of 3 active or 8 subjects of 6 active are planned for evaluation. Single dose followed by multiple dose, three times a day.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Six (6) cohorts of 1 placebo or 8 subjects of 2 placebo are planned for evaluation. Single dose followed by multiple dose, three times a day.

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 13.

Secondary Outcome Measure Information:

Title

Composite of PK parameters RPX2003 & placebo following single dose administration.

Description

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

Time Frame

Part 1A Study Day 1 to 3.

Title

Composite of PK parameters RPX2003 & placebo following multiple dose administration.

Description

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

Time Frame

Part 1B Day 4 to 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, 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. Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. beta-lactam antibiotics such as penicillins, carbapenems, etc). History of seizures (e.g., epilepsy). 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. Blood donation or significant blood loss (i.e., > 500 mL) within 56 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

Jeff Loutit, MBChB

Organizational Affiliation

Sponsor GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Celerion

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects

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