Safety and PK Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Minocin IV

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1, safety and PK Open-Label trial evaluating the plasma, epithelial lining fluid, and alveolar macrophage concentrations of intravenous Minocin® (Minocycline) for injection in healthy adult subjects.

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

Details

• Lead Sponsor: 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 hospital or after discharge, for the duration of the study;

2. Healthy adult male or female between 18 and 55 years of age (inclusive) at the time of Screening;

3. Body mass index (BMI) ≥ 18.5 and ≤ 30 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) at Screening;

4. Subject is in good health based on medical history and physical examination findings and has no clinically meaningful safety laboratory abnormalities (hematology, blood chemistry, and urinalysis) or 12-lead ECG results, as assessed by the Principal Investigator (PI);

5. Vital signs (blood pressure [BP], pulse, and temperature) measured at Screening/baseline must be within the following ranges: systolic BP ≥90 to ≤150 mm Hg, diastolic BP ≥45 to ≤90 mm Hg; Heart Rate ≥ 45 to ≤90 bpm (taken after resting in a supine position for at least 5 minutes);

6. 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;

7. Subject commits to remaining under observation of the study staff for the course of the study;

8. Female subject is surgically sterile (bilateral tubal occlusion), postmenopausal, or if of childbearing potential, agrees to abstinence or to use a highly efficient method of birth control (i.e., intrauterine device [IUD] or intrauterine hormone-releasing system [IUS] or vasectomized male partner, or hormonal contraceptives [estrogen and progestogen combined or progestogen only] with inhibition of ovulation; oral hormonal contraceptives must be supplemented with the use of condoms), between inclusion and for 7 days after the completion of the study;

9. If male, agree to be sexually abstinent or agree to use an approved method of contraception (e.g., condom with spermicide) when engaging in sexual activity from study check-in through 7 days after completion of the study, and to not donate sperm during this same period of time.

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. Any acute illness, including clinically significant infection within 30 days prior to Day 1;

3. Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant;

4. Positive breath test for alcohol on Day 1 (pre-dose) and/or positive urine test for drugs of abuse at Screening/Day -1 visit;

5. 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) and >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), or a glass of wine (100 mL);

6. Subject is a smoker and smokes >5 cigarettes per day (or equivalent);

7. Use of non-tobacco/nicotine-containing products within 6 months prior to Day 1;

8. Current diagnosis of or positive at Screening for HIV and/or Hepatitis B;

9. Blood or plasma donation within past 2 months;

10. Females who are pregnant or nursing or who have a positive pregnancy test result at Screening;

11. Presence of known raised intracranial pressure;

12. Use of isotretinoin;

13. History of significant hypersensitivity or allergic reaction to tetracycline antibiotics;

14. History of allergic or other serious adverse reactions to lidocaine;

15. Clinically significant pulmonary or any other disease that prevents a subject from undergoing bronchoscopy with bronchopulmonary lavage;

16. History of seizures (e.g., epilepsy), head injury, or meningitis requiring ongoing anti-seizure medications;

17. Receipt of any investigational medication or investigational device during the last 30 days prior to randomization;

18. Vigorous exercise from 48 hours prior to Day -1 until the day of discharge from the study;

19. Treatment with any prescription or over-the-counter drugs, within two weeks of day 1, with the exception of acetaminophen/paracetamol for minor headache. 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;

20. Unable or unwilling to comply with the protocol;

21. An employee of the PI or study center with direct involvement in the proposed study or other studies under the direction of that PI or study center, or a family member of the employee or the PI