HealthyPhase 1NCT03889366
Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers
A Phase 1 study testing Aprepitant 125 mg in people with Healthy, run by Nuformix Technologies Limited at 1 site in United Kingdom.
Trial summary
This study will compare the relative bioavailability of both an oral capsule formulation and an oral suspension formulation of NXP001 to Emend® in healthy male volunteers in the fasted state. 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
- Healthy
- What is being tested?
- Aprepitant 125 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Mar 2019to 30 Apr 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 males
- Body mass index (BMI) of 18.0 to 35.0 kg/m2 as assessed at screening
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to use adhere to the contraception requirements of the study
Who cannot join
- Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
- Current users of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
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- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- 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
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, psychiatric or gastrointestinal (GI) disease 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. Hayfever is allowed unless it is active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
- Subjects who have taken any CYP3A4 inducers in the 30 days prior to IMP administration.
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare the relative bioavailability of both an oral capsule formulation and an oral suspension formulation of NXP001 to Emend® in healthy male volunteers in the fasted state.
- Conditions
- Healthy
- Being tested
- Aprepitant 125 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant 125 mgDrug
Single dose in the fasted state during treatment period 1,2 or 3
| Study group | Role | What they receive |
|---|---|---|
| NXP001 Oral Capsule | Experimental | Not described Receives: Drug: Aprepitant 125 mg |
| NXP001 Oral Suspension | Experimental | Not described Receives: Drug: Aprepitant 125 mg |
| Emend® | Active comparator | Not described Receives: Drug: Aprepitant 125 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of NXP001 oral capsule, NXP001 oral suspension or Emend® in the fasted state
Measured: through 48 hours postdose
Secondary outcomes (1)
Peak Plasma Concentration (Cmax) Following Single Dose Administration of NXP001 oral capsule, NXP001 oral suspension or Emend® in the fasted state
Measured: through 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start20 Mar 2019
- Primary completion15 Apr 2019
- Study completion30 Apr 2019
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuformix Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889366
- Sponsor's protocol ID
- NXP001_01
- Status last verified
- Feb 2020
- First submitted
- 20 Mar 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03889366
- Acronym / sponsor ID
- NXP001_01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nuformix Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 26 Mar 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 compare the relative bioavailability of both an oral capsule formulation and an oral suspension formulation of NXP001 to Emend® in healthy male volunteers in the fasted state.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NXP001 Oral Capsule | Experimental | Drug: Aprepitant 125 mg |
| NXP001 Oral Suspension | Experimental | Drug: Aprepitant 125 mg |
| Emend® | Active comparator | Drug: Aprepitant 125 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males
- Body mass index (BMI) of 18.0 to 35.0 kg/m2 as assessed at screening
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to use adhere to the contraception requirements of the study
Key exclusion criteria (17 listed)
- Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
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 |
|---|---|---|
| Aprepitant 125 mgSingle dose in the fasted state during treatment period 1,2 or 3 | Drug | Emend®, NXP001 Oral Capsule, NXP001 Oral Suspension |
Primary outcome
Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of NXP001 oral capsule, NXP001 oral suspension or Emend® in the fasted state
Time frame: through 48 hours postdose
1 secondary outcome
Peak Plasma Concentration (Cmax) Following Single Dose Administration of NXP001 oral capsule, NXP001 oral suspension or Emend® in the fasted state
Time frame: through 48 hours postdose
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 25 Feb 2020.
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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 Aprepitant 125 mg in people with Healthy, run by Nuformix Technologies Limited 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 17 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 25 Feb 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?
Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of NXP001 oral capsule, NXP001 oral suspension or Emend® in the fasted state (time frame: through 48 hours postdose). 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 25 Feb 2020.