Acinetobacter Baumannii-calcoaceticus Complex InfectionsPhase 1NCT04018950
Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects
A Phase 1 study testing ETX2514 and 14C-ETX2514 in people with Acinetobacter Baumannii-calcoaceticus Complex Infections, run by Entasis Therapeutics at 1 site in United States.
Trial summary
This study will be conducted to determine the routes and rates of excretion of radio label arising from 14C-ETX2514 and to characterize metabolites of ETX2514 arising from 14C-ETX2514 administered intravenously in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acinetobacter Baumannii-calcoaceticus Complex Infections
- What is being tested?
- ETX2514 and 14C-ETX2514
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2019to 26 Jul 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants, between 18 and 55 years of age (inclusive) at the time of Screening
- Body mass index (BMI) ≥ 18.0 kilograms per meters squared (kg/m^2) and ≤ 32.0 kg/m^2 at Screening and weight between 55.0 and 100.0 kg (both inclusive) at Screening and Day -1
- Able to understand and willing to sign the Informed Consent Form (ICF), and willing and able to comply with the study restrictions and investigative site rules for participants
- Judged to be in good health in the opinion of the Investigator on the basis of a medical evaluation (including a physical examination, medical history, electrocardiograms vital signs, and the results of biochemistry and hematology tests and urinalysis carried out at Screening, Day -1 and pre-dose on Day 1) that does not reveal any clinically significant abnormality, which evaluation will consider acceptable the presence of a stable condition (e.g., hypertension, hyperlipidemia, diabetes mellitus, hypothyroidism) that may be under medical control (i.e., adequate and stable treatment) having no clinical consequences of the condition that, in the judgment of the Investigator, would increase risk to the participant's health by participating in this study or would increase risk of not achieving the study objectives
- Participants with normal renal function as evidenced by creatinine clearance (CLcr) estimated by Cockcroft Gault formula
- Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Screening.
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- Male participants with female partners of childbearing potential may be enrolled if they are:
- documented to be surgically sterile (vasectomy); or
- using two adequate forms of highly effective contraception (together with the female partner), out of which one will be a physical barrier (i.e., condom combined with partner oral contraceptive, implant, injectable, or indwelling intrauterine device), for 90 days after the study drug administration
- Must agree not to donate sperm from the Screening period through 90 days after the last dose
- Has sufficiently good venous access in both arms to confidently enable intravenous administration of study drug in one arm and serial blood sampling from the other arm
- Content of 14C in one or both (at Investigator's discretion) of urine and blood (or plasma) samples obtained at Screening does not significantly exceed the general environmental background 14C level
Who cannot join
- History or presence of oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychiatric or other disease or condition that in the Investigator's judgment poses a significant risk to the safety of the volunteer or the achievement of study objectives
- Clinically significant abnormal medical history, abnormal findings on physical examination, vital signs, electrocardiograms, or laboratory tests at Screening, Day -1 or pre-dose on Day 1 that the Investigator judges may put at risk achieving the objectives of the trial or protecting the safety of the volunteer
- History of cancer judged not to be in full remission for at least 5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for at least 1 year prior to screening), as judged by the Investigator
- Any acute illness including clinically significant infection within 30 days prior to Screening
- Acute illness within 14 days prior to study drug administration unless mild in severity and enrollment is approved by both Investigator and Sponsor's medical representative
- Presence of active infection requiring antibiotic treatment
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- History of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reaction
- Uncontrolled hyperuricemia (serum uric acid > upper limit of normal [ULN])
- Concomitant use of medications known to affect the elimination of serum creatinine (e.g., trimethoprim or cimetidine) or to compete for renal tubular secretion (e.g., probenecid) within 60 days prior to study drug administration
- Documented congenital or acquired long QT syndrome
- Corrected QT interval (QTc) using Fridericia correction (QTcF) at Screening, Day -1, or pre-dose (Day 1) > 450 milliseconds
- Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under age 50
- Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements with approximately 5 minutes of resting time between each measurement for systolic blood pressure [SBP] ≥ 140 millimeters of mercury (mmHg) and/or diastolic blood pressure [DBP] ≥ 100 mmHg
- Current presence of clinically significant hypotension (systolic blood pressure [SBP] < 90 mmHg and/or diastolic blood pressure [DBP] < 50 mmHg)
- Positive alcohol breath test or urine drug screen test at screening and/or Day -1
- Recent history of incomplete bladder emptying with voiding or of awaking more than once at night to void
- Usual habit of less than one or more than three bowel movements per day
- Positive testing for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
- History or presence of alcohol or drug abuse within the 2 years prior to Screening
- Excessive intake of alcohol, defined as an average daily intake of greater than three units, or an average weekly intake of greater than 21 units (one unit is equivalent to 1 can or bottle [12 ounces (oz)] of beer, or 1 measure [1.5 oz] of spirits, or 1 glass [5 oz] of wine) in the last 6 months prior to Screening
- Use of any prescription (including proton pump inhibitors [PPIs] and diuretics) or non-prescription drugs, including over-the-counter medication, health supplements, non-routine vitamins and herbal products such as St. John's Wort, within 2 weeks prior to study drug administration unless discussed and agreed with the Sponsor's medical representative in writing. Use of the following may be allowed within the 2 weeks prior to study drug administration:
- Topically applied medication (eye and/or nose drops/spray or creams/ointment/lotion applied to skin);
- Occasional use of metoclopramide or ibuprofen;
- Use of multivitamins, vitamin C (allowed up to 7 days prior to study drug administration), and acetaminophen (allowed up to 3 days prior to study drug administration).
- Use of caffeine or other xanthine containing products (coffee, black tea, green tea, decaffeinated coffee, decaffeinated tea, colas, kola, chocolate, cacao, guarana, guayusa, yerba mate), Seville oranges (sour/bitter or "marmalade"), grapefruit or grapefruit juice within 48 hours prior to study drug dosing
- History or evidence of difficulty with venous access or adverse symptoms in donating blood
- Participation in another investigational drug trial within 30 days prior to study drug administration (or 5 times the half-life of any drug used in the prior study, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to study drug administration
- Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug, or an occupationally exposed worker
- Participation in another clinical trial in which a [14C]-labeled drug was administered within the year prior to Day -1
- Donation or loss of more than 450 milliliters blood during the 3 months before the start of Screening
- Unwilling to avoid strenuous or unaccustomed activity, sunbathing, or contact sports within 96 hours (4 days) prior to entry in the clinic research center
- History of seizures, head injury with loss of consciousness or meningitis
- History of bleeding disorders
- Surgery within the past 3 months prior to Screening determined by the investigator to be clinically relevant
- Participants who have any of the following abnormalities on laboratory values at Screening or on Day -1 including:
- White blood cell count < 3000/millimeters cubed (mm^3), hemoglobin < 11 grams per deciliter (g/dL);
- Absolute neutrophil count < 1200/mm^3, platelet count < 120,000/mm^3;
- Serum Alkaline phosphatase (AP) > 1.5x ULN;
- Serum transaminase (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) > ULN
- Any other reason, condition or prior therapy, which, in the opinion of the Principal Investigator, would make the participant unsuitable for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaron Clinical Pharmacology Center
Baltimore, Maryland, 21201
About this study
Official title: Single Period, Open Label, Phase 1 Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects
This study will be conducted to determine the routes and rates of excretion of radio label arising from 14C-ETX2514 and to characterize metabolites of ETX2514 arising from 14C-ETX2514 administered intravenously in healthy participants.
- Being tested
- ETX2514, 14C-ETX2514
- Keywords
- Acinetobacter baumannii-calcoaceticus, complex infections, ETX2514, excretion, metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETX2514Drug
intravenous infusion
14C-ETX2514Drug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ETX2514 and 14C-ETX2514 | Experimental | Participants will receive a single intravenous infusion of 1 gram non-labeled ETX2514 and 1 microCurie (µCi) of 14C-ETX2514 in normal saline, administered as a 3-hour infusion. Receives: Drug: ETX2514; Drug: 14C-ETX2514 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative urinary recovery of total radioactivity
Measured: -12-0 hours (pre-dose), and at 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the initiation of the intravenous (IV) dose
Cumulative fecal recovery of total radioactivity
Measured: -12-0 hours (pre-dose), and at 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the initiation of the IV dose
Mass balance as a sum of the percent of total radioactivity recovered in urine and feces
Measured: urine: -12-0 hours (pre-dose), and at 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the IV dose; feces: -12-0 hours (pre-dose), and at 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the IV dose
Metabolite profiles in plasma
Measured: pre-dose (-30 minutes) and at 1, 2 (± 2 minutes), 3 (just prior to shutting off infusion), 4, 6, 8, 10, 12 (± 5 minutes), 18, 24, 36, 48, 72, 96, 120, 144, and 168 hours (± 10 minutes) after the initiation of the IV dose or early termination
Metabolite profiles in urine samples
Measured: -12-0 hours (pre-dose) and over the following collection periods: 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120,120-144, and 144-168 hours after the initiation of the IV dose
Metabolite profiles in fecal samples
Measured: -12-0 hours (pre-dose) and over the following collection periods: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the initiation of the IV dose
Secondary outcomes (5)
Number of participants with any treatment-emergent adverse event
Measured: up to Day 8
Number of participants with any clinically significant clinical laboratory evaluation
Measured: up to Day 8
Number of participants with any clinically significant vital sign measurement
Measured: up to Day 8
Number of participants with any clinically significant electrocardiogram finding
Measured: up to Day 8
Number of participants with any clinically significant physical examination finding
Measured: up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start21 Jun 2019
- Primary completion26 Jul 2019
- Study completion26 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acinetobacter Baumannii-calcoaceticus Complex InfectionsStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entasis Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018950
- Sponsor's protocol ID
- CS2514-2018-0002
- Status last verified
- Aug 2019
- First submitted
- 10 Jul 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Period, Open Label, Phase 1 Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04018950
- Acronym / sponsor ID
- CS2514-2018-0002
- Keywords
- Acinetobacter baumannii-calcoaceticus, complex infections, ETX2514, excretion, metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Entasis TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 15 Jul 2019 (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 study will be conducted to determine the routes and rates of excretion of radio label arising from 14C-ETX2514 and to characterize metabolites of ETX2514 arising from 14C-ETX2514 administered intravenously in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ETX2514 and 14C-ETX2514 | Experimental | Drug: ETX2514, Drug: 14C-ETX2514Participants will receive a single intravenous infusion of 1 gram non-labeled ETX2514 and 1 microCurie (µCi) of 14C-ETX2514 in normal saline, administered as a 3-hour infusion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male participants, between 18 and 55 years of age (inclusive) at the time of Screening
- Body mass index (BMI) ≥ 18.0 kilograms per meters squared (kg/m^2) and ≤ 32.0 kg/m^2 at Screening and weight between 55.0 and 100.0 kg (both inclusive) at Screening and Day -1
- Able to understand and willing to sign the Informed Consent Form (ICF), and willing and able to comply with the study restrictions and investigative site rules for participants
- Judged to be in good health in the opinion of the Investigator on the basis of a medical evaluation (including a physical examination, medical history, electrocardiograms vital signs, and the results of biochemistry and hematology tests and urinalysis carried out at Screening, Day -1 and pre-dose on Day 1) that does not reveal any clinically significant abnormality, which evaluation will consider acceptable the presence of a stable condition (e.g., hypertension, hyperlipidemia, diabetes mellitus, hypothyroidism) that may be under medical control (i.e., adequate and stable treatment) having no clinical consequences of the condition that, in the judgment of the Investigator, would increase risk to the participant's health by participating in this study or would increase risk of not achieving the study objectives
- Participants with normal renal function as evidenced by creatinine clearance (CLcr) estimated by Cockcroft Gault formula
Key exclusion criteria (40 listed)
- History or presence of oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychiatric or other disease or condition that in the Investigator's judgment poses a significant risk to the safety of the volunteer or the achievement of study objectives
- Clinically significant abnormal medical history, abnormal findings on physical examination, vital signs, electrocardiograms, or laboratory tests at Screening, Day -1 or pre-dose on Day 1 that the Investigator judges may put at risk achieving the objectives of the trial or protecting the safety of the volunteer
- History of cancer judged not to be in full remission for at least 5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for at least 1 year prior to screening), as judged by the Investigator
- Any acute illness including clinically significant infection within 30 days prior to Screening
- Acute illness within 14 days prior to study drug administration unless mild in severity and enrollment is approved by both Investigator and Sponsor's medical representative
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 |
|---|---|---|
| ETX2514intravenous infusion | Drug | ETX2514 and 14C-ETX2514 |
| 14C-ETX2514intravenous infusion | Drug | ETX2514 and 14C-ETX2514 |
Primary outcome
Cumulative urinary recovery of total radioactivity
Time frame: -12-0 hours (pre-dose), and at 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the initiation of the intravenous (IV) dose
Cumulative fecal recovery of total radioactivity
Time frame: -12-0 hours (pre-dose), and at 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the initiation of the IV dose
Mass balance as a sum of the percent of total radioactivity recovered in urine and feces
Time frame: urine: -12-0 hours (pre-dose), and at 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the IV dose; feces: -12-0 hours (pre-dose), and at 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the IV dose
Metabolite profiles in plasma
Time frame: pre-dose (-30 minutes) and at 1, 2 (± 2 minutes), 3 (just prior to shutting off infusion), 4, 6, 8, 10, 12 (± 5 minutes), 18, 24, 36, 48, 72, 96, 120, 144, and 168 hours (± 10 minutes) after the initiation of the IV dose or early termination
Metabolite profiles in urine samples
Time frame: -12-0 hours (pre-dose) and over the following collection periods: 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120,120-144, and 144-168 hours after the initiation of the IV dose
Metabolite profiles in fecal samples
Time frame: -12-0 hours (pre-dose) and over the following collection periods: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the initiation of the IV dose
5 secondary outcomes
Number of participants with any treatment-emergent adverse event
Time frame: up to Day 8
Number of participants with any clinically significant clinical laboratory evaluation
Time frame: up to Day 8
Number of participants with any clinically significant vital sign measurement
Time frame: up to Day 8
Number of participants with any clinically significant electrocardiogram finding
Time frame: up to Day 8
Number of participants with any clinically significant physical examination finding
Time frame: up to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ETX2514 and 14C-ETX2514 in people with Acinetobacter Baumannii-calcoaceticus Complex Infections, run by Entasis Therapeutics at 1 site in United States.
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 12 inclusion and 40 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: finished, as of the sponsor's last update on 30 Aug 2019. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative urinary recovery of total radioactivity (time frame: -12-0 hours (pre-dose), and at 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the initiation of the intravenous (IV) dose). The study lists 6 primary outcomes in all. 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 30 Aug 2019.