11 completed, 1 terminated. 9 Phase 1, 2 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 8, Terminated 1 |
| Phase 3 | 2 | Completed 2 |
| Phase 2 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin plazomicin, metformin - Healthy Volunteers | Phase 1 | Completed | Achaogen, Inc. | 16 | 2017-08-31 | 2017-10-11 |
| A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin [14C]-plazomicin - Healthy Volunteers | Phase 1 | Completed | Achaogen, Inc. | 6 | 2017-06-16 | 2017-07-12 |
| A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789 ACHN-383, ACHN-789, Placebo - Healthy Volunteers | Phase 1 | Completed | Achaogen, Inc. | 40 | 2017-05-17 | 2017-12-02 |
| A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP) plazomicin, meropenem, levofloxacin (oral) - Complicated Urinary Tract Infection, Acute Pyelonephritis | Phase 3 | Completed | Achaogen, Inc. | 609 | 2016-01-11 | 2018-08-23 |
| A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE) plazomicin, colistin, meropenem - Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE | Phase 3 | Completed | Achaogen, Inc. | 69 | 2014-09-16 | 2018-10-16 |
| A Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers ACHN-975, placebo - Healthy Volunteer | Phase 1 | Terminated | Achaogen, Inc. | 4 | 2013-05-01 | 2013-07-01 |
| A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers ACHN-975, placebo - Healthy Volunteer | Phase 1 | Completed | Achaogen, Inc. | 50 | 2012-05-01 | 2013-01-21 |
| A Study to Evaluate the Effect of IV ACHN-490 Injection on the QT/QTc Interval in Healthy Volunteers ACHN-490 Injection, Moxifloxacin, Placebo - Cardiac Effects in Normal Healthy Volunteers | Phase 1 | Completed | Achaogen, Inc. | 64 | 2011-10-01 | 2012-05-09 |
| PK Study of ACHN-490 Injection in Renally Impaired Subjects ACHN-490 Injection - Renal Insufficiency | Phase 1 | Completed | Achaogen, Inc. | 24 | 2011-09-01 | 2012-08-23 |
| A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP) levofloxacin, plazomicin, placebo - Complicated Urinary Tract Infection, Acute Pyelonephritis | Phase 2 | Completed | Achaogen, Inc. | 145 | 2010-07-13 | 2018-08-22 |
| Phase 1 Study to Determine Safety, Blood PK and Lung Penetration ACHN-490 Injection, Placebo (normal saline) - Healthy Volunteers | Phase 1 | Completed | Achaogen, Inc. | 40 | 2010-01-01 | 2012-02-27 |
| Phase 1 Study for Safety of ACHN-490 ACHN-490 Injection vs placebo - Healthy | Phase 1 | Completed | Achaogen, Inc. | 39 | 2009-01-01 | 2012-02-27 |
Bacterial Infections (2) · Pneumonia (1) · Pyelonephritis (1) · Renal Insufficiency (1) · Sepsis (1) · Urinary Tract Infections (1)
plazomicin (7) · ACHN-975 (2) · Levofloxacin (2) · Meropenem (2) · Colistin (1) · Metformin (1) · Moxifloxacin (1) · Saline Solution (1) · Tigecycline (1) · colistinmethanesulfonic acid (1)
United States (6) · Australia (1)
Lynn E Connolly, MD, PhD (2) · Shyeilla Dhuria (2) · Carter Brooks, MD (1) · Daniel J Cloutier, PharmD (1) · Nancy A Havrilla, MS, RN (1)
PMID 30275092, PMID 30605260, PMID 30650259, PMID 30786187, PMID 31254273
2015 (1)