NCT02808052

Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal Insufficiency

Terminated Phase 1 Results posted Last updated 4 September 2019

What this trial tests

Phase 1 trial testing Minocin (minocycline) for Injection in Renal Insufficiency, Acute in 9 participants. Terminated before completion.

Timeline

29 May 2017

Primary endpoint
4 June 2018

4 June 2018

Quick facts

Lead sponsor	Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	29 May 2017
Primary completion	4 June 2018
Estimated completion	4 June 2018
Sites	1 location across Germany

Drugs / interventions tested

• Minocin (minocycline) for Injection — full drug profile →

Conditions studied

• Renal Insufficiency, Acute — all drugs for Renal Insufficiency, Acute →
• Renal Insufficiency, Chronic — all drugs for Renal Insufficiency, Chronic →
• Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) — full company profile →

Who can join

Adults 18 to 85, any sex, with Renal Insufficiency, Acute or Renal Insufficiency, Chronic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events Primary · Approximately 24 weeks

Safety and Tolerability: Subjects with mild, moderate, or severe renal insufficiency with any adverse events, any serious adverse events, any study related adverse events, and any adverse events with a fatal outcome.

Number of subjects with any AE

Group	Value	95% CI
Mild Renal Insufficiency	1
Moderate Renal Insufficiency	2
Severe Renal Insufficiency	1

Number of subjects with any SAE

Group	Value	95% CI
Mild Renal Insufficiency	0
Moderate Renal Insufficiency	0
Severe Renal Insufficiency	0

Number of subjects with study related AE

Group	Value	95% CI
Mild Renal Insufficiency	0
Moderate Renal Insufficiency	1
Severe Renal Insufficiency	1

Number subjects with AE leading to fatal outcome

Group	Value	95% CI
Mild Renal Insufficiency	0
Moderate Renal Insufficiency	0
Severe Renal Insufficiency	0

Adverse events — posted to ClinicalTrials.gov

Time frame: All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mild Renal Insufficiency

Serious: 0/4 (0%)

Deaths: 0/4

Moderate Renal Insufficiency

Serious: 0/3 (0%)

Deaths: 0/3

Severe Renal Insufficiency

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (10 terms — click to expand)

Reaction	System	Mild Renal Insufficiency	Moderate Renal Insufficiency	Severe Renal Insufficiency
Headache	Nervous system disorders	—	—	—
Paraesthesia	Nervous system disorders	—	—	—
Haematoma	Vascular disorders	—	—	—
Ocular hyperaemia	Eye disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Sputum Abnormal	Investigations	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—
Hypoglycemia	Metabolism and nutrition disorders	—	—	—
Nightmare	Psychiatric disorders	—	—	—
Piloerection	Skin and subcutaneous tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT02808052 adverse events section.

Sponsor's own description

This is a Phase 1, open-label, single-dose study of the safety, tolerability, and pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal insufficiency.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.