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HealthyPhase 1NCT04654897

Mass Balance Study of [14C]-NT-814 Oral Suspension in Healthy Male Subjects

A Phase 1 study testing [14C]-NT-814 in people with Healthy, run by Bayer at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single centre, open-label, non-randomised study to assess the mass balance recovery, absorption, metabolism, and excretion of a single oral dose of [14C]-NT-814 in healthy male subjects. It is planned to enrol 6 subjects. Read more about this study

Who is it for?
Ages 30 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
[14C]-NT-814
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
30 Sep 2020to 29 Oct 2020
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 30 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males
  • Aged 30 to 65 years inclusive at the time of signing informed consent.
  • Body mass index (BMI) of 18.0 to 35.0 kg/m^2, inclusive, as measured at screening.
  • Must be able to understand the requirement of the study and be willing to participate in the whole study.
  • Must have regular bowel movements (i.e., usual stool production of ≥1 and ≤3 stools per day).
  • Must provide written informed consent.
  • Must agree to adhere to the contraception requirements

Who cannot join

  • Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1.
  • Subjects who are, or are immediate family members of, a study site or Sponsor employee.
  • Evidence of current SARS-CoV-2 infection.
  • History of any drug or alcohol abuse in the past 2 years.
  • Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).
  • A confirmed positive alcohol breath test at screening or admission.
Show all 26Show fewer
  • Current smokers and those who have smoked within the last 12 months.
  • A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.
  • Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
  • Subjects with pregnant or lactating partners.
  • Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 [7], shall participate in the study.
  • Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or delegate at screening.
  • Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the Investigator.
  • Subjects with biochemically verified Gilbert's Syndrome are allowed.
  • Subjects with a presence of any of the following at screening, confirmed by a repeat test: AST, alanine aminotransferase or, gamma glutamyl transferase above the upper limit of normal.
  • Confirmed positive drugs of abuse test result.
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
  • Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation.
  • History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the Investigator.
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
  • Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator.
  • Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood.
  • Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration.
  • History of GI surgery (with the exception of appendectomy unless it was performed within the previous 3 months).
  • Acute diarrhoea or constipation in the 7 days before the predicted Day 1.
  • Failure to satisfy the Investigator of fitness to participate for any other reason.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Sciences

    Ruddington, Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-NT-814 in Healthy Male Subjects After Oral Dosing

This is a single centre, open-label, non-randomised study to assess the mass balance recovery, absorption, metabolism, and excretion of a single oral dose of [14C]-NT-814 in healthy male subjects. It is planned to enrol 6 subjects. Each subject will receive a single dose of 120 mg [14C] NT-814 containing not more than (NMT) 5.6 megabecquerel (MBq) [14C], administered as an oral suspension in the fasted state. Subjects will remain in the study until a mass balance cumulative recovery of >90% and <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.

Read the detailed description

Subjects will undergo preliminary screening procedures for the study up to 28 days before [14C]-NT-814 administration. Subjects will be admitted in the evening on the day prior to [14C]-NT-814 administration (Day -1) at which time further screening procedures will be undertaken to confirm eligibility. Subjects will be dosed in the morning of Day 1 following an overnight fast of a minimum of 8 hours.

It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% and <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.

This may result in the subjects being discharged as a group prior to completion of the planned residency period. If the mass balance discharge criteria are achieved during the planned residency period, collection of all samples (blood, urine, and faeces) will be stopped and subjects will undergo discharge assessments. If mass balance discharge criteria have not been met by all subjects by Day 15, the residency period for the subjects not achieving the mass balance discharge criteria may be extended up to a maximum of 48 hours (i.e., up to Day 17). Blood, urine and faeces will be collected for 24 hour intervals during the extended residency period whilst the subjects are resident in the clinic.

If the mass balance discharge criteria are still not met by Day 17, subjects will enter a home collection phase during which they will collect 24-hour urine and faeces on a daily basis up until Day 24 (or until the criteria are met) and then on a weekly basis starting on Day 31 (until criteria met or Day 45 reached). During the period of weekly collection, mass balance cumulative recovery will be estimated by means of interpolation.

No additional collections will be performed for subjects who still do not meet the criteria on Day 45. Subjects entering the home collection phase will return on Day 19 ± 12 hours for blood sample collection. Discharge safety assessments will be performed at the time of actual discharge from the clinical unit.

Conditions
Healthy
Being tested
[14C]-NT-814

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-NT-814Drug

    120 mg radioactive labeled elinzanetant ([14C]-NT-814) oral suspension containing NMT (not more than) 5.6 MBq (megabecquerel) [14C].

Study groups in NCT04654897
Study groupRoleWhat they receive
Elinzanetant (NT-814, BAY3427080)ExperimentalSubjects received a single dose of 120 mg radioactive labeled elinzanetant ([14C]-NT-814) orally.
Receives: Drug: [14C]-NT-814

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mass Balance Recovery of Total Radioactivity: CumAe(Urine)

    CumAe(Urine): cumulative amount of Total Radioactivity (TR) excreted in urine.

    Measured: Day 45 (maximum)

  2. Mass Balance Recovery of Total Radioactivity: Cum%Ae(Urine)

    Cum%Ae(Urine): cumulative amount of TR excreted in urine expressed as a percentage of the radioactive dose administered.

    Measured: Day 45 (maximum)

  3. Mass Balance Recovery of Total Radioactivity: CumAe(Faeces)

    CumAe(Faeces): cumulative amount of TR excreted in faeces.

    Measured: Day 45 (maximum)

  4. Mass Balance Recovery of Total Radioactivity: Cum%Ae(Faeces)

    Cum%Ae(Faeces): cumulative amount of TR excreted in faeces expressed as a percentage of the radioactive dose administered.

    Measured: Day 45 (maximum)

  5. Mass Balance Recovery of Total Radioactivity: CumAe(Total)

    CumAe(Total): cumulative amount of TR excreted in urine and faeces combined. The radioactivity associated with toilet tissue was also determined, and the results were reported for each subject as a single value for the whole collection period only and included in the calculation of total Ae and % of dose recovered. The data reported for total calculations excluded toilet tissue data for the 0 - 6 hours post-dose to 0 - 456 hours post-dose collection intervals and included toilet tissue data for the 0 - 480 hours post-dose collection interval.

    Measured: Day 45 (maximum)

  6. Mass Balance Recovery of Total Radioactivity: Cum%Ae(Total)

    Cum%Ae(Total): cumulative amount of TR excreted in urine and faeces combined expressed as a percentage of the radioactive dose administered. The radioactivity associated with toilet tissue was also determined, and the results were reported for each subject as a single value for the whole collection period only and included in the calculation of total Ae and % of dose recovered. The data reported for total calculations excluded toilet tissue data for the 0 - 6 hours post-dose to 0 - 456 hours post-dose collection intervals and included toilet tissue data for the 0 - 480 hours post-dose collection interval.

    Measured: Day 45 (maximum)

Secondary outcomes (22)

  1. AUC(0-tlast) of NT-814 (in plasma)

    AUC(0-tlast): Area under the curve from time 0 to the time of last measurable concentration.

    Measured: Day 45 (maximum)

  2. AUC(0-tlast) of Total Radioactivity (in plasma and whole blood)

    AUC(0-tlast): Area under the curve from time 0 to the time of last measurable concentration.

    Measured: Day 45 (maximum)

  3. Cmax of NT-814 (in plasma)

    Cmax: Maximum observed concentration.

    Measured: Day 45 (maximum)

  4. Cmax of Total Radioactivity (in plasma and whole blood)

    Cmax: Maximum observed concentration.

    Measured: Day 45 (maximum)

  5. Ae(urine) by interval

    Ae(urine): amount of TR excreted in urine.

    Measured: Day 45 (maximum)

  6. %Ae(urine) by interval

    %Ae(urine): amount of TR excreted in urine expressed as a percentage of the radioactive dose administered.

    Measured: Day 45 (maximum)

  7. Ae(faeces) by interval

    Ae(faeces): amount of TR excreted in faeces.

    Measured: Day 45 (maximum)

  8. %Ae(faeces) by interval

    %Ae(faeces): amount of TR excreted in faeces expressed as a percentage of the radioactive dose administered.

    Measured: Day 45 (maximum)

  9. Ae(total) by interval

    Ae(total): amount of TR excreted in urine and faeces combined.

    Measured: Day 45 (maximum)

  10. %Ae(total) by interval

    %Ae(total): amount of TR excreted in urine and faeces combined expressed as a percentage of the radioactive dose administered.

    Measured: Day 45 (maximum)

  11. CumAe(urine) by interval

    CumAe(urine): cumulative amount of TR excreted in urine.

    Measured: Day 45 (maximum)

  12. %CumAe(urine) by interval

    %CumAe(urine): cumulative amount of TR excreted in urine expressed as a percentage of the radioactive dose administered.

    Measured: Day 45 (maximum)

  13. CumAe(faeces) by interval

    CumAe(faeces): cumulative amount of TR excreted in faeces.

    Measured: Day 45 (maximum)

  14. %CumAe(faeces) by interval

    %CumAe(faeces): cumulative amount of TR excreted in faeces expressed as a percentage of the radioactive dose administered.

    Measured: Day 45 (maximum)

  15. CumAe(total) by interval

    CumAe(total): cumulative amount of TR excreted in urine and faeces combined. H=hour. The radioactivity associated with toilet tissue was also determined, and the results were reported for each subject as a single value for the whole collection period only and included in the calculation of total Ae and % of dose recovered. The data reported for total calculations excluded toilet tissue data for the 0 - 6 hours post-dose to 0 - 456 hours post-dose collection intervals and included toilet tissue data for the 0 - 480 hours post-dose collection interval.

    Measured: Day 45 (maximum)

  16. %CumAe(total) by interval

    %CumAe(total): cumulative amount of TR excreted in urine and faeces combined expressed as a percentage of the radioactive dose administered. H=hour. The radioactivity associated with toilet tissue was also determined, and the results were reported for each subject as a single value for the whole collection period only and included in the calculation of total Ae and % of dose recovered. The data reported for total calculations excluded toilet tissue data for the 0 - 6 hours post-dose to 0 - 456 hours post-dose collection intervals and included toilet tissue data for the 0 - 480 hours post-dose collection interval.

    Measured: Day 45 (maximum)

  17. Evaluation of the extent of distribution of Total Radioactivity (TR) into blood cells

    Plasma concentration ratios for TR is reported.

    Measured: Up to 45 days

  18. Number of subjects with treatment-emergent adverse events

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject that does not necessarily have a causal relationship with treatment. Treatment-emergent AEs are AEs that commenced during/after the administration of investigational medicinal product (IMP) or commenced before administration of IMP (i.e., a pre-dose AE or existing medical condition) but worsened in intensity during exposure to IMP.

    Measured: Up to 45 days

  19. Laboratory Evaluations - number of subjects with clinically important changes in hematology and clinical chemistry parameters from baseline

    Measured: Baseline, 24 hours post-baseline and at Discharge

  20. Vital Signs - number of subjects with clinically important changes in systolic and diastolic blood pressure and heart rate from baseline

    Measured: Baseline, 1 hour, 4 hours, 24 hours post-baseline and at Discharge

  21. Number of subjects with clinically relevant findings in electrocardiogram (ECG) parameters from baseline

    Measured: Baseline, 1 hour, 4 hours, 24 hours post-baseline and at Discharge

  22. Number of subjects with clinically significant abnormal findings in physical examination

    Measured: Up to 45 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2020
  2. Study start30 Sep 2020
  3. Primary completion29 Oct 2020
  4. Study completion29 Oct 2020

Resources

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
Model description
Open Label, single dose
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04654897
Sponsor's protocol ID
21664
Other IDs
2020-002987-30
Status last verified
Oct 2021
First submitted
25 Nov 2020
Last updated
28 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • Schulz SI, Schultze-Mosgau MH, Engelen A, Singh N, Pawsey S, Francke K, Lock R, Rottmann A. Mass Balance Recovery, Absorption, Metabolism, and Excretion of Elinzanetant in Healthy Human Volunteers and in vitro Biotransformation. Eur J Drug Metab Pharmacokinet. 2025 Jan;50(1):91-103. doi: 10.1007/s13318-024-00930-3. Epub 2024 Dec 24.

    PubMed 39719488

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-NT-814 in people with Healthy, run by Bayer at 1 site in United Kingdom.

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 7 inclusion and 26 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 28 Oct 2021. 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 Kingdom. 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?

Mass Balance Recovery of Total Radioactivity: CumAe(Urine) (time frame: Day 45 (maximum)). 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?

On the ClinicalTrials.gov record for NCT04654897, which also lists 1 linked publication.

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 28 Oct 2021.

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