HealthyPhase 1NCT04387981
Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male Subjects
A Phase 1 study testing [14C]-orvepitant in people with Healthy, run by Nerre Therapeutics Ltd. at 1 site in United Kingdom.
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]-orvepitant 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]-orvepitant
- 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
- 1 Jun 2020to 28 Jun 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/m2 as measured at screening.
- Must provide written informed consent.
- Must agree to adhere to the contraception requirements
Who cannot join
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption >21 units per week.
- Current smokers and those who have smoked within the last 12 months.
- 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.
- Clinically significant abnormal clinical chemistry, haematology, or urinalysis as judged by the Investigator.
- Subjects with a presence of any of the following at screening: bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >1.5 × the upper limit of normal.
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- Confirmed positive drugs of abuse test result.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 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, chronic respiratory, or GI disease, neurological or psychiatric disorder, as judged by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] Orvepitant 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]-orvepitant in healthy male subjects. It is planned to enrol 6 subjects. Each subject will receive a single dose of 30 mg [14C] orvepitant containing not more than (NMT) 3.7 megabecquerel (MBq) [14C], administered as an oral solution in the fasted state. Subjects will be admitted in the evening on the day prior to [14C]-orvepitant administration and will be dosed in the morning following an overnight fast. It is planned that subjects will remain resident in the clinical unit until 168 hours post-dose (Day 8) when they will be discharged from the clinical unit. Through the resident period samples (blood, urine, faeces) will be collected and analysed for mass balance, total radioactivity, orvepitant levels. Metabolite profiling and ID will also be performed.
- Conditions
- Healthy
- Being tested
- [14C]-orvepitant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-orvepitantDrug
Also called orvepitant
Oral solution of [14C]-orvepitant
| Study group | Role | What they receive |
|---|---|---|
| [14C]-orvepitant | Experimental | [14C]-orvepitant administered as 30mg single dose in oral solution Receives: Drug: [14C]-orvepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of radioactive dose recovered in urine and faeces and total percentage
Measured: 168 hours
Concentration of total radioactivity in blood and plasma
Measured: 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Jun 2020
- Primary completion28 Jun 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single dose
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nerre Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387981
- Sponsor's protocol ID
- ORV-1-02
- Status last verified
- Aug 2020
- First submitted
- 7 May 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] Orvepitant in Healthy Male Subjects After Oral Dosing
- ClinicalTrials.gov ID
- NCT04387981
- Acronym / sponsor ID
- ORV-1-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nerre Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 28 Jun 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 14 May 2020 (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 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]-orvepitant in healthy male subjects. It is planned to enrol 6 subjects. Each subject will receive a single dose of 30 mg [14C] orvepitant containing not more than (NMT) 3.7 megabecquerel (MBq) [14C], administered as an oral solution in the fasted state. Subjects will be admitted in the evening on the day prior to [14C]-orvepitant administration and will be dosed in the morning following an overnight fast. It is planned that subjects will remain resident in the clinical unit until 168 hours post-dose (Day 8) when they will be discharged from the clinical unit. Through the resident period samples (blood, urine, faeces) will be collected and analysed for mass balance, total radioactivity, orvepitant levels. Metabolite profiling and ID will also be performed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single dose
| Arm | Type | Receives |
|---|---|---|
| [14C]-orvepitant | Experimental | Drug: [14C]-orvepitant[14C]-orvepitant administered as 30mg single dose in oral solution |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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/m2 as measured at screening.
- Must provide written informed consent.
- Must agree to adhere to the contraception requirements
Key exclusion criteria (10 listed)
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption >21 units per week.
- Current smokers and those who have smoked within the last 12 months.
- 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.
- Clinically significant abnormal clinical chemistry, haematology, or urinalysis as judged by the Investigator.
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 |
|---|---|---|
| [14C]-orvepitantAlso: orvepitantOral solution of [14C]-orvepitant | Drug | [14C]-orvepitant |
Primary outcome
Percentage of radioactive dose recovered in urine and faeces and total percentage
Time frame: 168 hours
Concentration of total radioactivity in blood and plasma
Time frame: 168 hours
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 7 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Principal Investigator principal investigator
Quotient Sciences
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 [14C]-orvepitant in people with Healthy, run by Nerre Therapeutics Ltd. 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 10 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 7 Aug 2020. 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?
Percentage of radioactive dose recovered in urine and faeces and total percentage (time frame: 168 hours). The study lists 2 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 7 Aug 2020.