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Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers

Sponsor
Nuformix Technologies Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT03889366
Collaborator
(none)
12
Enrollment
1
Location
3
Arms
1.3
Actual Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aprepitant 125 mg
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers
Actual Study Start Date :
Mar 20, 2019
Actual Primary Completion Date :
Apr 15, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: NXP001 Oral Capsule

Drug: Aprepitant 125 mg
Single dose in the fasted state during treatment period 1,2 or 3
Experimental: NXP001 Oral Suspension

Drug: Aprepitant 125 mg
Single dose in the fasted state during treatment period 1,2 or 3
Active Comparator: Emend®

Drug: Aprepitant 125 mg
Single dose in the fasted state during treatment period 1,2 or 3

Outcome Measures

Primary Outcome Measures

  1. 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 [through 48 hours postdose]

Secondary Outcome Measures

  1. Peak Plasma Concentration (Cmax) Following Single Dose Administration of NXP001 oral capsule, NXP001 oral suspension or Emend® in the fasted state [through 48 hours postdose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Healthy males

  2. Body mass index (BMI) of 18.0 to 35.0 kg/m2 as assessed at screening

  3. Must be willing and able to communicate and participate in the whole study

  4. Must provide written informed consent

  5. Must agree to use adhere to the contraception requirements of the study

Exclusion Criteria:

  1. Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose

  2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee

  3. History of any drug or alcohol abuse in the past 2 years

  4. 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)

  5. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening

  6. Current users of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months

  7. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening

  8. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator

  9. Confirmed positive drugs of abuse test result

  10. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results

  11. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, psychiatric or gastrointestinal (GI) disease as judged by the investigator

  12. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

  13. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active

  14. Donation or loss of greater than 400 mL of blood within the previous 3 months

  15. 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.

  16. Subjects who have taken any CYP3A4 inducers in the 30 days prior to IMP administration.

  17. Failure to satisfy the investigator of fitness to participate for any other reason

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quotient Sciences Limited Nottingham United Kingdom NG11 6JS

Sponsors and Collaborators

  • Nuformix Technologies Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nuformix Technologies Limited
ClinicalTrials.gov Identifier:
NCT03889366
Other Study ID Numbers:
  • NXP001_01
First Posted:
Mar 26, 2019
Last Update Posted:
Feb 25, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Aprepitant

Study Results

No Results Posted as of Feb 25, 2020