Normal Healthy VolunteersPhase 1NCT03291158
Safety and PK Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Minocin IV
A Phase 1 study testing Minocycline in people with Normal Healthy Volunteers, run by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Volunteers
- What is being tested?
- Minocycline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2018to Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 9Show fewer
- Subject commits to remaining under observation of the study staff for the course of the study;
- 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;
- 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.
Who cannot join
- 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);
Show all 21Show fewer
- 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;
- History of seizures (e.g., epilepsy), head injury, or meningitis requiring ongoing anti-seizure medications;
- Receipt of any investigational medication or investigational device during the last 30 days prior to randomization;
- Vigorous exercise from 48 hours prior to Day -1 until the day of discharge from the study;
- 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;
- Unable or unwilling to comply with the protocol;
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-Label Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Minocin (Minocylcine) for Injection
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.
Read the detailed description
The purpose of this study is to evaluate the safety of Minocin IV and measure plasma, epithelial lining fluid, and alveolar macrophage drug levels after six doses of Minocin IV given 12 hours apart, administered as 1-hour infusions in healthy adult subjects.
- Conditions
- Normal Healthy Volunteers
- Being tested
- Minocycline
- Keywords
- Bacterial Infections
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Minocin IV
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.
| Study group | Role | What they receive |
|---|---|---|
| Minocycline IV | Experimental | Open label Minocin IV Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze plasma, ELF and Alveolar Macrophage concentrations of minocycline
Determine plasma ELF and Alveolar Macrophage concentrations of minocycline when administered to healthy adult subjects.
Measured: 16 weeks
Secondary outcomes (1)
Safety and Tolerability
To assess the safety and tolerability of Minocin IV when administered to healthy adult subjects by assessing adverse events, changes from baseline in physical examination findings, clinical safety laboratory test results, ECGs, and vital signs throughout the study.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study startApr 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitätsklinikum Köln, Innovative Medicines Initiative
- Responsible party
- Sponsor
- Investigators
- Markus Zeitlinger, MD, Principal investigator, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291158
- Sponsor's protocol ID
- MDCO-MIN-16-04
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2017
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Minocin (Minocylcine) for Injection
- ClinicalTrials.gov ID
- NCT03291158
- Acronym / sponsor ID
- MDCO-MIN-16-04
- Conditions
- Normal Healthy Volunteers
- Keywords
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)Industry (pharma, biotech, devices)
- Collaborators
- Universitätsklinikum Köln, Innovative Medicines Initiative
- Study start
- Apr 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to evaluate the safety of Minocin IV and measure plasma, epithelial lining fluid, and alveolar macrophage drug levels after six doses of Minocin IV given 12 hours apart, administered as 1-hour infusions in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minocycline IV | Experimental | Drug: MinocyclineOpen label Minocin IV |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (21 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineAlso: Minocin IVSubjects 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. | Drug | Minocycline IV |
Primary outcome
Analyze plasma, ELF and Alveolar Macrophage concentrations of minocycline
Time frame: 16 weeks
Determine plasma ELF and Alveolar Macrophage concentrations of minocycline when administered to healthy adult subjects.
1 secondary outcome
Safety and Tolerability
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Normal Healthy Volunteers
Active, not recruitingEarly Phase 1
A Trial of HRS-3095 in Healthy Volunteers
Chronic Spontaneous Urticaria
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Zeitlinger, MD principal investigator
University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minocycline in people with Normal Healthy Volunteers, run by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze plasma, ELF and Alveolar Macrophage concentrations of minocycline (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.