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Trial record 72 of 734 for:    Area Under Curve AND Bioavailability

Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03889366
Recruitment Status : Active, not recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Nuformix Technologies Limited

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

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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
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aprepitant

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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889366


Locations
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United Kingdom
Quotient Sciences Limited
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Nuformix Technologies Limited

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Responsible Party: Nuformix Technologies Limited
ClinicalTrials.gov Identifier: NCT03889366    
Other Study ID Numbers: NXP001_01
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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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:
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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