Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-19

Study Completion Date

2018-08-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase I, randomized, single-blind, parallel group, placebo-controlled, multi-cohort, first-in-human dose escalation study of a single IV 3-hour administration of Cilastatin as stand-alone in healthy male and female volunteers.

The study objectives are:

The evaluation of safety and tolerability of single intravenous doses of cilastatin in healthy volunteers administered as a 3-hour infusion.

The evaluation of the pharmacokinetic characteristics of Cilastatin after a single 3-hour infusion dose.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects

NCT01577589

Healthy

COMPLETED PHASE1

Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of UCB5857 in Healthy Subjects

NCT02207595

Healthy Volunteers

COMPLETED PHASE1

A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction

NCT05224609

Moderate Hepatic Impairment Severe Hepatic Impairment Healthy Volunteers

COMPLETED PHASE1

Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519

NCT03210649

Dyslipidemia

COMPLETED PHASE1

Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide

NCT05097716

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is designed as a phase I, randomized, single-blind, parallel group, placebo-controlled, multi-cohort, first-in-human dose escalation study of a single IV 3-hour administration of Cilastatin as stand-alone in healthy male and female volunteers.

The study will involve 24 healthy male and female healthy subjects, divided in three study cohorts (8 subjects per cohort). The study is a dose escalating study, starting from 3 g of Cilastatin administered intravenously in 3 hours.

Eight subjects will be randomized and assigned to either the study drug or placebo group for each study cohort in a 3:1 ratio (6 actives and 2 placebos). Randomization will also be gender balanced within each study cohort. The planned dose escalation scheme should not occur before participants in the previous dose level have been treated and safety profile of Cilastatin from those participants are assessed in accordande with the protocol.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dose Finding Study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cilastatin Dose 1

Starting dose (3g of Cilastatin) Single intravenous administration during 3 hours.

Group Type EXPERIMENTAL

Cilastatin

Intervention Type DRUG

Dose escalation 3-hour single intravenous administration

Cilastatin Dose 2

Dose escalation Single intravenous administration during 3 hours.

Group Type EXPERIMENTAL

Cilastatin

Intervention Type DRUG

Dose escalation 3-hour single intravenous administration

Cilastatin Dose 3

Dose escalation Single intravenous administration during 3 hours.

Group Type EXPERIMENTAL

Cilastatin

Intervention Type DRUG

Dose escalation 3-hour single intravenous administration

Placebo

Saline solution for infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3-hour single intravenous administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cilastatin

Dose escalation 3-hour single intravenous administration

Intervention Type DRUG

Placebo

3-hour single intravenous administration

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cilastatin sodium

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male or female subjects, 18-45 years (inclusive) of age at the time of enrolment.
* Male and female subjects willing and able to give their written consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and their right to withdraw from the study at any time and for any reason.
* Body weight within normal range (Quetelet's index between 19 and 30 expressed as kg/m2 and weigh at least 50 kg and no more than 100 kg inclusive).
* Normal clinical records and physical examination.
* Laboratory tests (hematology, biochemistry and urine analysis) within the range of normal values, per the Biochemistry laboratory reference values of the 'Hospital Universitario La Paz'. Variations may be admitted per the clinical criteria of the clinical investigator.
* Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
* To be able to understand the nature of the study and comply with all their requirements.

Exclusion Criteria

* Women of childbearing potential who planned to become pregnant, were pregnant and/or breast-feeding, or did not wish to use an effective contraceptive method (hormonal contraceptives \[implant, patches, oral\]) or double-barrier methods \[any double combination of: IUD, male or female prophylactics with spermicidal gel, diaphragm, contraceptive sponge, cervical cap\]).
* History of alcohol dependence or drug abuse in the last 1 year or daily consumption of alcohol \> 40 g/day for men or 24 g/day for women.
* Heavy consumer of stimulating beverages (\>5 coffees, teas, chocolate or cola drinks per day).
* Background of allergy, idiosyncrasy or hypersensitivity to drugs.
* Intake of any medication within 4 days prior and during visit 2 or Xanthine containing foods or beverages or herbal remedies that could interfere with pharmacokinetics of the study drug, except allowed contraceptive medication for female subjects.
* Positive serology for hepatitis B, C or HIV.
* Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological or neurological disease or other chronic diseases.
* Twelve lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec, bradycardia (\<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval.
* Having undergone major surgery during the previous 6 months.
* Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc.) from 6 months prior to drug administration.
* Participation in another clinical trial during the 3 months preceding the drug administration.
* Donation of blood during the 4 weeks preceding the drug administration.
* Acute illness within four weeks before drug administration.
* Clinically significant abnormal laboratory values (as determined by the PI) at the screening evaluation.
* Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract
* Positive results of the drugs at screening period or at visit 2. A minimum list of 6 drugs will be screened for inclusion: Amphetamines, Cocaine, Ethanol, Opiates, Benzodiazepines and Cannabinoids (positive results may be repeated at the discretion of the investigator team).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes