Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Aprepitant 125 mg

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Sciences Limited

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nuformix Technologies Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Neurokinin-1 Receptor Antagonists; Aprepitant
• Other Study ID Numbers: NXP001_01

Drug and device information, study documents

• 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