Healthy VolunteersPhase 1NCT04962724
A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male Participants
A Phase 1 study testing Radiolabelled Xevinapant 200 mg (Oral Solution), Radiolabelled Xevinapant 100 μg (IV Solution) and Xevinapant 200 mg (Oral Solution) in people with Healthy Volunteers, run by Debiopharm International SA at 1 site in United Kingdom.
Trial summary
The purpose of the study is to determine absorption, metabolism, and excretion of a single oral dose of [14C]-xevinapant. This information will enable assessment of absorption and clearance mechanisms of [14C]-xevinapant as well as identify metabolites. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Radiolabelled Xevinapant 200 mg (Oral Solution), Radiolabelled Xevinapant 100 μg (IV Solution) and Xevinapant 200 mg (Oral Solution)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2021to 9 Nov 2021
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1: Males of any race, between 35 and 65 years of age, inclusive. Part 2: Males of any race, between 18 and 65 years of age, inclusive
- Body mass index between 18.0 and 30.0 kilograms per meter square (kg/m^2), inclusive
- Weight between 50 kilograms (kg) and 110 kg, inclusive
- History of a minimum of 1 bowel movement per day.
- Willing to adhere to the prohibitions and restrictions specified in the study protocol
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)
- History of alcohol consumption of >21 units per week. One unit of alcohol equals 12 ounce (oz) [360 millilitre (mL)] beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing, or less than 5 times the half-life, whichever is longer, prior to administration of study drug
- Poor peripheral venous access
- Have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, 2-part, Single-dose Study of the Absorption, Metabolism, and Excretion of Oral [14C]-Xevinapant, and Absolute Oral Bioavailability of Xevinapant in Healthy Male Subjects
The purpose of the study is to determine absorption, metabolism, and excretion of a single oral dose of [14C]-xevinapant. This information will enable assessment of absorption and clearance mechanisms of [14C]-xevinapant as well as identify metabolites. In addition, the study will allow to determine absolute bioavailability of xevinapant and understand its intravenous pharmacokinetics.
- Conditions
- Healthy Volunteers
- Being tested
- Radiolabelled Xevinapant 200 mg (Oral Solution), Radiolabelled Xevinapant 100 μg (IV Solution), Xevinapant 200 mg (Oral Solution)
- Keywords
- Xevinapant, Absorption, Distribution, Metabolism and Excretion (ADME), Mass balance, Absolute bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiolabelled Xevinapant 200 mg (Oral Solution)Drug
[14C]-Xevinapant 200 mg administered as an oral solution on Day 1 of Part 1, containing approximately 100 microcurie (μCi) [3.7 megabecquerel (MBq)] in fasted conditions.
Radiolabelled Xevinapant 100 μg (IV Solution)Drug
100 μg [14C]-xevinapant single dose administered as an IV bolus on Day 1, containing approximately 0.2 μCi [7.4 kilobecquerel (kBq)].
Xevinapant 200 mg (Oral Solution)Drug
Xevinapant 200 mg administered as an oral solution on Day 1 of Part 2 in fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Radiolabeled Xevinapant Oral Solution | Experimental | Participants will receive:
• single oral dose of [14C]-xevinapant, as an oral solution Receives: Drug: Radiolabelled Xevinapant 200 mg (Oral Solution) |
| Radiolabeled Xevinapant Intravenous Solution + Xevinapant Oral Solution | Experimental | Participants will receive:
• single oral dose of xevinapant, as an oral solution followed by an IV bolus of [14C]-xevinapant, solution for infusion Receives: Drug: Radiolabelled Xevinapant 100 μg (IV Solution); Drug: Xevinapant 200 mg (Oral Solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance Recovery Measured Through Total Radioactivity Excreted in Expired Air, Urine and Feces
Measured: Up to Day 29
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity); Time 0 to 24 Hours (AUC0-24); Time 0 to Last Quantifiable Concentration (AUC0-last) of Total Radioactivity in Blood and Plasma, and of Xevinapant and Metabolite in Plasma
Measured: Up to Day 29
Maximum Observed Concentration (Cmax) of Total Radioactivity in Blood and Plasma, and of Xevinapant and Metabolite in Plasma
Measured: Up to Day 29
Time to Maximum Observed Concentration (Tmax) of Total Radioactivity in Blood and Plasma, and of Xevinapant and Metabolite in Plasma
Measured: Up to Day 29
Apparent Terminal Elimination Half-life (T1/2) of Total Radioactivity in Blood and Plasma, and of Xevinapant and Metabolite in Plasma
Measured: Up to Day 29
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Total Radioactivity in Blood and Plasma, and of Xevinapant and Metabolite in Plasma
Measured: Up to Day 29
Apparent Total Clearance (CL/F) of Total Radioactivity in Blood and Plasma and of Xevinapant and Metabolite in Plasma
Measured: Up to Day 29
Renal Clearance (CLr) of Total Radioactivity, Xevinapant and Metabolite
Measured: Up to Day 29
Xevinapant Metabolite Concentrations in Urine, Feces, Blood and Plasma
Measured: Up to Day 8
Absolute Bioavailability (F) of Xevinapant in Plasma
Absolute Bioavailability (F) = (AUC0-infinity [oral]/ dose [oral]) /(AUC0-infinity [IV]/ dose [IV])
Measured: Up to Day 5
Secondary outcomes (7)
Blood to Plasma Ratio of Xevinapant and Metabolite
Measured: Up to Day 8
Plasma Protein Binding Expressed as Fraction unbound, fu of Xevinapant
Measured: Up to Day 8
Safety and Tolerability as Measured by Number of Participants With Treatment-Emergent Adverse Events
Measured: Up to Day 29
Safety and Tolerability as Measured by Number of Participants With Clinically significant Laboratory Abnormalities
Measured: Up to Day 29
Safety and Tolerability as Measured by Number of Participants With Clinically significant 12-lead ECG Parameters Abnormalities
Measured: Up to Day 29
Safety and Tolerability as Measured by Number of Participants With Clinically significant Vital Signs Abnormalities
Measured: Up to Day 29
Safety and Tolerability as Measured by Number of Participants With Clinically significant Physical Examination Abnormalities
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start2 Aug 2021
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962724
- Sponsor's protocol ID
- Debio 1143-108
- Status last verified
- Dec 2021
- First submitted
- 21 Jun 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 2-part, Single-dose Study of the Absorption, Metabolism, and Excretion of Oral [14C]-Xevinapant, and Absolute Oral Bioavailability of Xevinapant in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04962724
- Acronym / sponsor ID
- Debio 1143-108
- Conditions
- Healthy Volunteers
- Keywords
- Xevinapant, Absorption, Distribution, Metabolism and Excretion (ADME), Mass balance, Absolute bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 15 Jul 2021 (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.
The purpose of the study is to determine absorption, metabolism, and excretion of a single oral dose of [14C]-xevinapant. This information will enable assessment of absorption and clearance mechanisms of [14C]-xevinapant as well as identify metabolites. In addition, the study will allow to determine absolute bioavailability of xevinapant and understand its intravenous pharmacokinetics.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiolabeled Xevinapant Oral Solution | Experimental | Drug: Radiolabelled Xevinapant 200 mg (Oral Solution)Participants will receive: • single oral dose of [14C]-xevinapant, as an oral solution |
| Radiolabeled Xevinapant Intravenous Solution + Xevinapant Oral Solution | Experimental | Drug: Radiolabelled Xevinapant 100 μg (IV Solution), Drug: Xevinapant 200 mg (Oral Solution)Participants will receive: • single oral dose of xevinapant, as an oral solution followed by an IV bolus of [14C]-xevinapant, solution for infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Part 1: Males of any race, between 35 and 65 years of age, inclusive. Part 2: Males of any race, between 18 and 65 years of age, inclusive
- Body mass index between 18.0 and 30.0 kilograms per meter square (kg/m^2), inclusive
- Weight between 50 kilograms (kg) and 110 kg, inclusive
- History of a minimum of 1 bowel movement per day.
- Willing to adhere to the prohibitions and restrictions specified in the study protocol
Key exclusion criteria (5 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)
- History of alcohol consumption of >21 units per week. One unit of alcohol equals 12 ounce (oz) [360 millilitre (mL)] beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing, or less than 5 times the half-life, whichever is longer, prior to administration of study drug
- Poor peripheral venous access
- Have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in.
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 |
|---|---|---|
| Radiolabelled Xevinapant 200 mg (Oral Solution)[14C]-Xevinapant 200 mg administered as an oral solution on Day 1 of Part 1, containing approximately 100 microcurie (μCi) [3.7 megabecquerel (MBq)] in fasted conditions. | Drug | Radiolabeled Xevinapant Oral Solution |
| Radiolabelled Xevinapant 100 μg (IV Solution)100 μg [14C]-xevinapant single dose administered as an IV bolus on Day 1, containing approximately 0.2 μCi [7.4 kilobecquerel (kBq)]. | Drug | Radiolabeled Xevinapant Intravenous Solution + Xevinapant Oral Solution |
| Xevinapant 200 mg (Oral Solution)Xevinapant 200 mg administered as an oral solution on Day 1 of Part 2 in fasted conditions | Drug | Radiolabeled Xevinapant Intravenous Solution + Xevinapant Oral Solution |
Primary outcome
Mass Balance Recovery Measured Through Total Radioactivity Excreted in Expired Air, Urine and Feces
Time frame: Up to Day 29
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity); Time 0 to 24 Hours (AUC0-24); Time 0 to Last Quantifiable Concentration (AUC0-last) of Total Radioactivity in Blood and Plasma, and of Xevinapant and Metabolite in Plasma
Time frame: Up to Day 29
Maximum Observed Concentration (Cmax) of Total Radioactivity in Blood and Plasma, and of Xevinapant and Metabolite in Plasma
Time frame: Up to Day 29
Time to Maximum Observed Concentration (Tmax) of Total Radioactivity in Blood and Plasma, and of Xevinapant and Metabolite in Plasma
Time frame: Up to Day 29
Apparent Terminal Elimination Half-life (T1/2) of Total Radioactivity in Blood and Plasma, and of Xevinapant and Metabolite in Plasma
Time frame: Up to Day 29
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Total Radioactivity in Blood and Plasma, and of Xevinapant and Metabolite in Plasma
Time frame: Up to Day 29
Apparent Total Clearance (CL/F) of Total Radioactivity in Blood and Plasma and of Xevinapant and Metabolite in Plasma
Time frame: Up to Day 29
Renal Clearance (CLr) of Total Radioactivity, Xevinapant and Metabolite
Time frame: Up to Day 29
Xevinapant Metabolite Concentrations in Urine, Feces, Blood and Plasma
Time frame: Up to Day 8
Absolute Bioavailability (F) of Xevinapant in Plasma
Time frame: Up to Day 5
Absolute Bioavailability (F) = (AUC0-infinity [oral]/ dose [oral]) /(AUC0-infinity [IV]/ dose [IV])
7 secondary outcomes
Blood to Plasma Ratio of Xevinapant and Metabolite
Time frame: Up to Day 8
Plasma Protein Binding Expressed as Fraction unbound, fu of Xevinapant
Time frame: Up to Day 8
Safety and Tolerability as Measured by Number of Participants With Treatment-Emergent Adverse Events
Time frame: Up to Day 29
Safety and Tolerability as Measured by Number of Participants With Clinically significant Laboratory Abnormalities
Time frame: Up to Day 29
Safety and Tolerability as Measured by Number of Participants With Clinically significant 12-lead ECG Parameters Abnormalities
Time frame: Up to Day 29
Safety and Tolerability as Measured by Number of Participants With Clinically significant Vital Signs Abnormalities
Time frame: Up to Day 29
Safety and Tolerability as Measured by Number of Participants With Clinically significant Physical Examination Abnormalities
Time frame: Up to Day 29
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 27 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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 Radiolabelled Xevinapant 200 mg (Oral Solution), Radiolabelled Xevinapant 100 μg (IV Solution) and Xevinapant 200 mg (Oral Solution) in people with Healthy Volunteers, run by Debiopharm International SA 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 5 inclusion and 5 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 27 Dec 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 Measured Through Total Radioactivity Excreted in Expired Air, Urine and Feces (time frame: Up to Day 29). The study lists 10 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 27 Dec 2021.