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

• Status: Completed
• Trial end date: 2018-02-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.); Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
• Collaborators: Innovative Medicines Initiative; The Medicines Company; Universitätsklinikum Köln
• Treatments: Minocycline

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