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Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin® (Minocycline) for Injection in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02802631
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
Universitätsklinikum Köln
Innovative Medicines Initiative
Information provided by (Responsible Party):
Melinta Therapeutics, Inc. ( Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) )

Tracking Information
First Submitted Date  ICMJE June 9, 2016
First Posted Date  ICMJE June 16, 2016
Last Update Posted Date May 2, 2018
Actual Study Start Date  ICMJE April 20, 2017
Actual Primary Completion Date February 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2016)
Safety and tolerability of single and multiple intravenous doses of Minocin (minocycline) for Injection assessed by number of subjects with adverse events, serious adverse events, vital signs, and physical exam and clinical laboratory results [ Time Frame: Approximately 25 weeks ]
Safety and Tolerability
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2016)
  • Assessment of area under the concentration-time curve from zero hours to the last measured concentration (AUC0-t) for single and multiple intravenous doses of Minocin (minocycline) for Injection using plasma from serial blood samples [ Time Frame: Approximately 25 weeks ]
    Pharmacokinetics
  • Assessment of area under the concentration-time curve from zero hours extrapolated to infinity (AUC0-inf) for single and multiple intravenous doses of Minocin (minocycline) for Injection using plasma from serial blood samples [ Time Frame: Approximately 25 weeks ]
    Pharmacokinetics
  • Assessment of maximum plasma concentration (Cmax) for single and multiple intravenous doses of Minocin (minocycline) for Injection using serial blood samples [ Time Frame: Approximately 25 weeks ]
    Pharmacokinetics
  • Assessment of time to maximum plasma concentration (Tmax) for single and multiple intravenous doses of Minocin (minocycline) for Injection using serial blood samples [ Time Frame: Approximately 25 weeks ]
    Pharmacokinetics
  • Assessment of dose proportionality for single and multiple intravenous doses of Minocin (minocycline) for Injection using plasma from serial blood samples [ Time Frame: Approximately 25 weeks ]
    Pharmacokinetics
  • Assessment of amount of drug excreted in urine for single and multiple intravenous doses of Minocin (minocycline) for Injection using serial urine samples [ Time Frame: Approximately 25 weeks ]
    Pharmacokinetics
  • Assessment of percent dose of drug excreted in urine for single and multiple intravenous doses of Minocin (minocycline) for Injection using serial urine samples [ Time Frame: Approximately 25 weeks ]
    Pharmacokinetics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin® (Minocycline) for Injection in Healthy Adults
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics of Minocin® (Minocycline) for Injection in Healthy Adult Subjects
Brief Summary This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin® (minocycline) for injection in healthy adult subjects.
Detailed Description The purpose of this study is to collect safety, tolerability, and PK data on ascending dose regimens of Minocin® (minocycline) for Injection. The safety, tolerability, and PK data will support the compound as a potential clinical candidate in Europe and allow recommendations of dose levels to be used in future Phase 2/3 studies.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Normal Healthy Volunteers
Intervention  ICMJE
  • Drug: Minocin (minocycline) for Injection
    Intravenous formulation of minocycline, a derivative of tetracycline
    Other Names:
    • Minocin
    • minocycline
  • Other: Placebo
    Placebo - Normal Saline
Study Arms  ICMJE
  • Experimental: Minocin for Injection (minocycline)
    Minocin (minocycline for injection) for 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 one of the following dosages of Minocin (minocycline) for Injection: 100 mg, 200 mg, 300 mg, 400 mg, or 500 mg. Within each cohort, subjects will receive a single dose on Day 1, followed by 7 days of multiple-doses (Days 4-10, given every 12 hours), followed by a single dose on Day 11.
    Intervention: Drug: Minocin (minocycline) for Injection
  • Placebo Comparator: 0.9% Sodium Chloride Injection USP
    Placebo is in the form of the same 100-mL bags of normal saline (0.9% Sodium Chloride Injection USP). Dosing is to the same schedule as subjects randomized to Minocin (minocycline) for Injection.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2018)
61
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2016)
50
Actual Study Completion Date  ICMJE February 8, 2018
Actual Primary Completion Date February 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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 research unit or after discharge, for the duration of the study;
  2. Male or female between 18 and 50 years of age inclusive;
  3. Subject has a body mass index (BMI) ≥18 kg/m2 and ≤ 30 kg/m2;
  4. Subject is non-smoker or smokes up to 5 cigarettes per day (or equivalent).
  5. Subject is in good health based on medical history and physical examination findings and has no clinically meaningful safety laboratory abnormalities (Haematology, blood chemistry, and urinalysis) or 12-lead ECG results, as assessed by the Principal Investigator (PI);
  6. Vital signs (BP, pulse, respiratory rate and temperature) measured at screening/baseline must be within the following ranges: SBP ≥90 to ≤150 mm Hg, DBP ≥45 to ≤90 mm Hg; Heart Rate ≥ 45 to ≤90 bpm (taken after resting in a supine position for at least 5 minutes);
  7. Expectation that intravenous access will be sufficient to allow for ease of study drug infusion, and for all protocol required blood sampling to take place;
  8. Subject commits to remaining admitted in the research unit for the course of the study;
  9. Female subject is surgically sterile, postmenopausal: period of amenorrhea for at least 2 years, 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 the first dose (Day 1) and for 90 days after the completion of the study.

Exclusion Criteria:

  1. Has any condition, including findings in the medical history or in pre-study assessments that constitutes a risk or a contraindication for the participation in the study or completing the study;
  2. Positive breath test for alcohol and/or positive urine test for drugs of abuse at Screening and Day -1 Visits;
  3. Has a history or presence of alcohol/drug abuse within 2 years. Alcohol abuse is defined as regularly consuming >3 units/day (21 units per week for men), >2 units/day (14 units/week) for women. A unit is defined as a can of 4% beer (330 mL), approximately 190 mL of 6-7% beer (malt liquor), a glass of 40% spirits (30 mL), a glass of wine (100 mL);
  4. Subject shows positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus (HIV) I/II antibodies and antigen tests;
  5. Subject has active or ongoing candida infection;
  6. Blood or plasma donation within past 2 months;
  7. Females who are pregnant or nursing or who have a positive pregnancy test result at the Screening Visit or Day -1 prior to dosing;
  8. Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period and for 90 days after the completion of the study (i.e. condom with spermicide, where locally available);
  9. Presence of known raised intracranial pressure;
  10. Use of retinoids (e.g., Isotretinoin);
  11. History of significant hypersensitivity or allergic reaction to any of the tetracycline class of antibiotics or the components of those antibiotics;
  12. Receipt of any investigational medication or investigational device during the last 30 days prior to randomization;
  13. Treatment with any prescription, vitamins or OTC drugs, within 2 weeks or five half-lives, whichever is longer, or herbal nutritional supplements within 2 weeks of screening, with the exception of acetaminophen/paracetamol for minor headache. Subjects will not be allowed to receive medications for the duration of the study (except the abovementioned acetaminophen/paracetamol). Birth control or other hormone replacement is also permitted as long as it has been taken at a stable dose for at least three months before the Screening Visit and remains stable for the duration of the study;
  14. A QTcF >480 msec;
  15. Calculated creatinine clearance less than 50 mL/min (Cockcroft-Gault method) at screening or check-in (Day -1)
  16. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol;
  17. An employee of the Investigator, the study center, the sponsor or The Medicines Company with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, or a family member of the employee or the Investigator;
  18. Prior enrollment in any minocycline study including prior cohorts in this trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT02802631
Other Study ID Numbers  ICMJE MDCO-MIN-16-02
701 (IMI WP8A ID #) ( Other Identifier: The Medicines Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Melinta Therapeutics, Inc. ( Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) )
Study Sponsor  ICMJE Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Collaborators  ICMJE
  • Universitätsklinikum Köln
  • Innovative Medicines Initiative
Investigators  ICMJE
Principal Investigator: Dr. Naguib Muhsen, MD QPS
PRS Account Melinta Therapeutics, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP