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

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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.) )

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.

Condition or disease Intervention/treatment Phase
Normal Healthy Volunteers Drug: Minocin (minocycline) for Injection Other: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : February 8, 2018
Actual Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Minocin (minocycline) for Injection
Intravenous formulation of minocycline, a derivative of tetracycline
Other Names:
  • Minocin
  • minocycline

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.
Other: Placebo
Placebo - Normal Saline




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802631


Locations
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Netherlands
QPS
Groningen, AG, Netherlands, 9713
Sponsors and Collaborators
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Universitätsklinikum Köln
Innovative Medicines Initiative
Investigators
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Principal Investigator: Dr. Naguib Muhsen, MD QPS
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Responsible Party: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
ClinicalTrials.gov Identifier: NCT02802631    
Other Study ID Numbers: MDCO-MIN-16-02
701 (IMI WP8A ID #) ( Other Identifier: The Medicines Company )
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Melinta Therapeutics, Inc. ( Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) ):
Bacterial infections
Additional relevant MeSH terms:
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Minocycline
Anti-Bacterial Agents
Anti-Infective Agents