NCT03889366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

26 days

First QC Date

March 20, 2019

Last Update Submit

February 24, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (3)

NXP001 Oral Capsule

EXPERIMENTAL
Drug: Aprepitant 125 mg

NXP001 Oral Suspension

EXPERIMENTAL
Drug: Aprepitant 125 mg

Emend®

ACTIVE COMPARATOR
Drug: Aprepitant 125 mg

Interventions

Aprepitant 125 mgDRUG

Single dose in the fasted state during treatment period 1,2 or 3

Emend®NXP001 Oral CapsuleNXP001 Oral Suspension

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Sciences Limited

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Aprepitant

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 26, 2019

Study Start

March 20, 2019

Primary Completion

April 15, 2019

Study Completion

April 30, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

GB(1)