Trial Outcomes & Findings for Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal Insufficiency (NCT NCT02808052)
NCT ID: NCT02808052
Last Updated: 2019-09-04
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Approximately 24 weeks
Results posted on
2019-09-04
Participant Flow
A total of 9 subjects were assigned to one of three groups (Mild, Moderate, or Severe) based on degree of renal impairment. All 9 subjects were enrolled in the study from 29-May-2017 to 17-Dec- 2017, at the Univ Hosp Cologne, Germany.
Following the change of ownership of Minocin IV from The Medicines Company to Melinta Therapeutics, the business decision was made to terminate this study prior to completion as Melinta.
Participant milestones
| Measure |
Mild Renal Insufficiency
Mild renal insufficiency (eGFR 60-89 mL/min/1.73m2)
|
Moderate Renal Insufficiency
Moderate renal insufficiency (eGFR 30 to \< 60 mL/min/1.73m2)
|
Severe Renal Insufficiency
Severe renal insufficiency (eGFR \< 30 mL/min/1.73m2), not receiving hemodialysis (HD) therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
2
|
|
Overall Study
COMPLETED
|
4
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal Insufficiency
Baseline characteristics by cohort
| Measure |
Mild Renal Insufficiency
n=4 Participants
Mild renal insufficiency (eGFR 60-89 mL/min/1.73m2)
|
Moderate Renal Insufficiency
n=3 Participants
Moderate renal insufficiency (eGFR 30 to \< 60 mL/min/1.73m2)
|
Severe Renal Insufficiency
n=2 Participants
Severe renal insufficiency (eGFR \< 30 mL/min/1.73m2), not receiving HD therapy
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.25 years
STANDARD_DEVIATION 19.60 • n=5 Participants
|
65.00 years
STANDARD_DEVIATION 11.53 • n=7 Participants
|
54.00 years
STANDARD_DEVIATION 2.83 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 17.65 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Height
|
179.0 cm
STANDARD_DEVIATION 4.08 • n=5 Participants
|
176.67 cm
STANDARD_DEVIATION 7.02 • n=7 Participants
|
179.00 cm
STANDARD_DEVIATION 1.41 • n=5 Participants
|
178.22 cm
STANDARD_DEVIATION 4.49 • n=4 Participants
|
|
Weight
|
80.98 kg
STANDARD_DEVIATION 28.44 • n=5 Participants
|
99.40 kg
STANDARD_DEVIATION 2.08 • n=7 Participants
|
111.05 kg
STANDARD_DEVIATION 48.01 • n=5 Participants
|
93.80 kg
STANDARD_DEVIATION 27.59 • n=4 Participants
|
PRIMARY outcome
Timeframe: Approximately 24 weeksPopulation: All subjects (9) subjects who received at least one dose of study drug were included in the safety population used for safety analyses.
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.
Outcome measures
| Measure |
Mild Renal Insufficiency
n=4 Participants
Mild renal insufficiency (eGFR 60-89 mL/min/1.73m2)
|
Moderate Renal Insufficiency
n=3 Participants
Moderate renal insufficiency (eGFR 30 to \< 60 mL/min/1.73m2)
|
Severe Renal Insufficiency
n=2 Participants
Severe renal insufficiency (eGFR \< 30 mL/min/1.73m2), not receiving HD therapy
|
|---|---|---|---|
|
Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events
Number subjects with AE leading to fatal outcome
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events
Number of subjects with any AE
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events
Number of subjects with any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events
Number of subjects with study related AE
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Mild Renal Insufficiency
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Moderate Renal Insufficiency
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Severe Renal Insufficiency
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mild Renal Insufficiency
n=4 participants at risk
Mild renal insufficiency (eGFR 60-89 mL/min/1.73m2)
|
Moderate Renal Insufficiency
n=3 participants at risk
Moderate renal insufficiency (eGFR 30 to \< 60 mL/min/1.73m2)
|
Severe Renal Insufficiency
n=2 participants at risk
Severe renal insufficiency (eGFR \< 30 mL/min/1.73m2), not receiving HD therapy
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/4 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
0.00%
0/3 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
50.0%
1/2 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
33.3%
1/3 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
0.00%
0/2 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
|
Vascular disorders
Haematoma
|
25.0%
1/4 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
33.3%
1/3 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
0.00%
0/2 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
0.00%
0/3 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
50.0%
1/2 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
0.00%
0/3 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
50.0%
1/2 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
|
Investigations
Sputum Abnormal
|
0.00%
0/4 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
0.00%
0/3 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
50.0%
1/2 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
33.3%
1/3 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
0.00%
0/2 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/4 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
33.3%
1/3 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
50.0%
1/2 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/4 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
33.3%
1/3 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
0.00%
0/2 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
|
Skin and subcutaneous tissue disorders
Piloerection
|
0.00%
0/4 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
0.00%
0/3 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
50.0%
1/2 • All Adverse Events (AEs) occurring from the time when first dose was administered up to the last follow-up visit (Day 6) where collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place