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NCT01702649 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy Volunteers and Bacterial Infections, sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company).

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT01702649 is a Phase 1 study of Healthy Volunteers and Bacterial Infections that has completed, run by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company). The registered enrollment target is 36 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01702649, a Phase 1 study of Healthy Volunteers and Bacterial Infections, has completed, sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company).

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Placebo
  • DRUG RPX2003 (Biapenem)

Study Locations (1)

Arizona

  • Celerion - Tempe

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2012-08
Est. Completion 2012-11
Phase Phase 1

What the Registry Record Tells You About NCT01702649

The ClinicalTrials.gov registry entry for NCT01702649 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The listed sponsor is Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company), which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01702649 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT01702649 about?

NCT01702649 is a clinical study titled "Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects". RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.

What is the current status of trial NCT01702649?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-08. Estimated completion is 2012-11.

What conditions does trial NCT01702649 study?

This clinical trial studies the following conditions: Healthy Volunteers, Bacterial Infections.

What interventions are being tested in trial NCT01702649?

The interventions under investigation include: Placebo (DRUG), RPX2003 (Biapenem) (DRUG).

Who is sponsoring clinical trial NCT01702649?

This trial is sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company), which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01702649 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.