ClinicalTrials.gg
CompletedNCT04018950Updated Aug 30, 2019

Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects

A Phase 1 interventional study of ETX2514 and 14C-ETX2514 in Acinetobacter Baumannii-calcoaceticus Complex Infections, sponsored by Entasis Therapeutics. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by Entasis Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2019, 7 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Acinetobacter Baumannii-calcoaceticus Complex Infections

Keywords

  • Acinetobacter baumannii-calcoaceticus
  • complex infections
  • ETX2514
  • excretion
  • metabolism
03

In context

Lead sponsor

Entasis Therapeutics is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy male participants, between 18 and 55 years of age (inclusive) at the time of Screening
  • (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 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, 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 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 (CLcr) estimated by Cockcroft Gault formula
  • Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Screening.
  • Male participants with female partners of may be enrolled if they are:

    1. documented to be surgically sterile (vasectomy); or
    2. using two adequate forms of highly effective (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

Exclusion criteria

Exclusion Criteria:

  • 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
  • abnormal medical history, abnormal findings on physical examination, vital signs, , 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
  • History of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reaction
  • Uncontrolled hyperuricemia (serum uric acid > [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 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 (HIV), , or
  • 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:

    1. Topically applied medication (eye and/or nose drops/spray or creams/ointment/lotion applied to skin);
    2. Occasional use of metoclopramide or ibuprofen;
    3. 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 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:

    1. White blood cell count \< 3000/millimeters cubed (mm\^3), \< 11 grams per deciliter (g/dL);
    2. \< 1200/mm\^3, count \< 120,000/mm\^3;
    3. Serum Alkaline phosphatase (AP) > 1.5x ULN;
    4. Serum transaminase ( [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
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    ETX2514 and 14C-ETX2514

    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.

    Drug: ETX2514 · Drug: 14C-ETX2514

Interventions

  • intravenous infusion

  • Drug14C-ETX2514

    intravenous infusion

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Number of participants with any treatment-emergent adverse event

    Time frame: up to Day 8

  2. Number of participants with any clinically significant clinical laboratory evaluation

    Time frame: up to Day 8

  3. Number of participants with any clinically significant vital sign measurement

    Time frame: up to Day 8

  4. Number of participants with any clinically significant electrocardiogram finding

    Time frame: up to Day 8

  5. Number of participants with any clinically significant physical examination finding

    Time frame: up to Day 8

07

Study locations

1 site
  • Pharmaron Clinical Pharmacology Center
    Baltimore, Maryland 21201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04018950
Lead sponsor
Entasis Therapeutics
Responsible party
Sponsor
First posted
Jul 15, 2019
Start date
Jun 21, 2019
Primary completion
Jul 26, 2019
Completion
Jul 26, 2019
Last update
Aug 30, 2019

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Durlobactam

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