Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects

NCT01897779 | Completed Phase 1

• 1 other identifier: Rempex 501
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

RPX7009 (beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014) to treat bacterial infections, including those due to multi-drug resistant bacteria.

Conditions

Healthy Volunteers; Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  Study Day 1 to Day 14

Secondary Outcomes (1)

• Composite of PK parameters RPX7009, RPX2014, combination of RPX7009 and RPX2014 & placebo following single and multiple dose administration.

  Study Day1 to Day 14

Study Arms (4)

Single and multiple dose of RPX7009

EXPERIMENTAL

Single and multiple dose of RPX7009

Drug: RPX7009

Single and multiple dose of RPX2014

EXPERIMENTAL

Single and multiple dose of RPX2014

Drug: RPX2014

Normal Saline

PLACEBO COMPARATOR

Single and multiple dose of normal saline

Drug: Placebo

Combination RPX7009 and RPX2014

EXPERIMENTAL

Single and Multiple dose of Combination RPX7009 and RPX2014

Drug: Combination RPX7009 and RPX2014

Interventions

RPX7009 DRUG

Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

Also known as: (beta-lactamase inhibitor)

Single and multiple dose of RPX7009

RPX2014 DRUG

Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

Single and multiple dose of RPX2014

Placebo DRUG

Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

Also known as: Normal saline

Normal Saline

Combination RPX7009 and RPX2014 DRUG

Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.

Combination RPX7009 and RPX2014

Eligibility Criteria

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

You may qualify if:

• Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening.
• 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 (e.g., laboratory profiles, medical histories, ECGs, physical examination) as deemed by the PI.
• Non-tobacco/nicotine-containing product users for a minimum of Dose Study 6 months prior to Day 1.
• Voluntarily consent to participate in the study.
• Sexually abstinent or agree to use two approved methods of contraception.

You may not qualify if:

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• Positive urine drug/alcohol testing at screening or check-in (Day -1).
• Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
• History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
• 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.
• Plasma donation within 7 days prior to Day 1.
• Participation in another investigational clinical trial within 30 days prior to Day 1.
• Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).

Sponsors & Collaborators

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

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

• Rubino CM, Bhavnani SM, Loutit JS, Morgan EE, White D, Dudley MN, Griffith DC. Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Vaborbactam and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02228-17. doi: 10.1128/AAC.02228-17. Print 2018 Apr.

  PMID: 29437614 DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

RPX7009; beta-Lactamase Inhibitors; Saline Solution

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anti-Bacterial Agents; Anti-Infective Agents; Therapeutic Uses; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jeffery Loutit

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 12, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

AU (1)