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

NCT03291158 | Withdrawn Phase 1

• 1 other identifier: MDCO-MIN-16-04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Healthy Volunteers

Keywords

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Analyze plasma, ELF and Alveolar Macrophage concentrations of minocycline

  Determine plasma ELF and Alveolar Macrophage concentrations of minocycline when administered to healthy adult subjects.

  16 weeks

Secondary Outcomes (1)

• Safety and Tolerability

  16 weeks

Study Arms (1)

Minocycline IV

EXPERIMENTAL

Open label Minocin IV

Drug: Minocycline

Interventions

Minocycline DRUG

Subjects will be assigned into 5 cohorts of 5 subjects each, who will receive six doses of Minocin IV every 12 hours, starting on Day 1. Each dose of Minocin IV will be administered as an IV infusion over 1 hour. Subjects will be assigned to cohort based on time of bronchoalveolar lavage.

Also known as: Minocin IV

Minocycline IV

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 55 years of age (inclusive) at the time of Screening;
• Body mass index (BMI) ≥ 18.5 and ≤ 30 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) at Screening;
• 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);
• 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);
• 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;
• Subject commits to remaining under observation of the study staff for the course of the study;
• 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.

You may not qualify if:

• 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;
• Any acute illness, including clinically significant infection within 30 days prior to Day 1;
• Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant;
• Positive breath test for alcohol on Day 1 (pre-dose) and/or positive urine test for drugs of abuse at Screening/Day -1 visit;
• 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);
• Subject is a smoker and smokes \>5 cigarettes per day (or equivalent);
• Use of non-tobacco/nicotine-containing products within 6 months prior to Day 1;
• Current diagnosis of or positive at Screening for HIV and/or Hepatitis B;
• Blood or plasma donation within past 2 months;
• Females who are pregnant or nursing or who have a positive pregnancy test result at Screening;
• Presence of known raised intracranial pressure;
• Use of isotretinoin;
• History of significant hypersensitivity or allergic reaction to tetracycline antibiotics;
• History of allergic or other serious adverse reactions to lidocaine;
• Clinically significant pulmonary or any other disease that prevents a subject from undergoing bronchoscopy with bronchopulmonary lavage;

Sponsors & Collaborators

• Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company): lead
• Universitätsklinikum Köln: collaborator
• Innovative Medicines Initiative: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Markus Zeitlinger, MD

  University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 25, 2017
• Study Start: April 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)