A Phase I, Open-Label, Single-Dose Trial To Determine The Safety And Pharmacokinetics Of Minocin (Minocycline) For Injection In Subjects With Renal Insufficiency
Overview
- Phase
- Phase 1
- Intervention
- Minocin (minocycline) for Injection
- Conditions
- Renal Insufficiency, Acute
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
The purpose of this study is to collect safety, tolerability, and pharmacokinetics (PK) data on a single dose of Minocin® (minocycline) for Injection in subjects with renal insufficiency and in subjects receiving hemodialysis therapy. The safety, tolerability, and PK data will support the compound as a potential clinical candidate in Europe and will inform the development of future Phase 2/3 studies.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A signed informed consent form, the ability to understand the study conduct and tasks that are required for study participation, and a willingness to cooperate with all tasks, tests, and examinations as required by the protocol, whether in the hospital or after discharge, for the duration of the study;
- •Healthy adult male or female between 18 and 85 years of age (inclusive) at the time of screening;
- •Subject has a body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 45 kg/m2;
- •Pulse measured at screening/baseline must be within the ranges ≥ 45 to ≤ 115 beats per minute (bpm, taken after resting in a semi-recumbent position for at least 5 minutes);
- •Have sufficient peripheral vascular access, based on the Investigator's assessment, for all blood sample collections to take place;
- •Female subject is surgically sterile, postmenopausal, or if of childbearing potential, agrees to abstinence or to use at least 2 acceptable methods of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier methods, etc.) or male partner sterilization alone, between randomization and for 7 days after the completion of the study;
- •Subjects with Renal Insufficiency:
- •Assessment of renal insufficiency for assignment to study groups will be based on measurements of estimated glomerular filtration rate calculated by the Modification of Diet in Renal Disease equation at the screening visit to determine eligibility;
- •Subjects with Normal Renal Function:
- •Normal volunteers first matched by age (± 10 years), BMI (± 20%), and gender to the mean values of the moderate renal insufficiency group. Once the mild, moderate, and severe renal insufficiency groups are fully enrolled, the mean values of age, BMI, and gender will be calculated for the pooled renal insufficiency groups, and additional healthy subjects may be enrolled to match the pooled means;
Exclusion Criteria
- •Has any condition, including findings in the medical history or in pre-study assessments, that are capable of altering the distribution, metabolism, or elimination of drugs or that constitute a risk or a contraindication for the participation in the study or completing the study; Subjects in the renal insufficiency groups will have consideration for the degree of renal insufficiency and presence of comorbidities;
- •Current evidence or history of malignancy, excluding basal cell carcinoma, in the 2 years prior to Day -1 (day before dosing) with no evidence of recurrence;
- •Blood or plasma donation within past 2 months;
- •Vigorous exercise from 48 hours prior to Day -1 until the day of discharge from the study;
- •Surgery within 48 hours prior to randomization or surgery planned during the study period;
- •Liver function abnormalities at screening (or Day -1) (defined by an elevation in bilirubin, aspartate aminotransferase, or alanine aminotransferase that is 1.5 x upper limit of normal of the normal range for subjects based on age and sex);
- •Females who are pregnant or nursing or who have a positive pregnancy test result;
- •Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period (i.e., condom with spermicide, where locally available);
- •Presence of known raised intracranial pressure;
- •Use of isotretinoin;
Arms & Interventions
Minocin (minocycline) for Injection
Minocin (minocycline) for Injection will be supplied as a sterile lyophilized powder in single-use 10-mL glass vials. Each vial contains 108 mg of minocycline hydrochloride equivalent to 100 mg of minocycline. Each cohort receives a single 200-mg dose of Minocin (minocycline) for Injection except for the hemodialysis therapy/end stage renal disease cohort, which receives two 200-mg doses.
Intervention: Minocin (minocycline) for Injection
Outcomes
Primary Outcomes
Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events
Time Frame: 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.