Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT03889366
• Recruitment Status: Completed
• First Posted: March 26, 2019
• Last Update Posted: February 25, 2020
• Sponsor: Nuformix Technologies Limited
• Information provided by (Responsible Party): Nuformix Technologies Limited

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
Healthy	Drug: Aprepitant 125 mg	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: March 20, 2019
• Actual Primary Completion Date: April 15, 2019
• Actual Study Completion Date: April 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 [ Time Frame: 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 [ Time Frame: through 48 hours postdose ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

United Kingdom

Quotient Sciences Limited

Nottingham, United Kingdom, NG11 6JS

Sponsors and Collaborators

Nuformix Technologies Limited

More Information

• Responsible Party: Nuformix Technologies Limited
• ClinicalTrials.gov Identifier: NCT03889366
• Other Study ID Numbers: NXP001_01
• First Posted: March 26, 2019
• Last Update Posted: February 25, 2020
• Last Verified: February 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; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Neurokinin-1 Receptor Antagonists; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action