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Trial of Safety and Tolerability of Oral Verdinexor (KPT-335) in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02431364
Recruitment Status : Completed
First Posted : May 1, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Brief Summary:
This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on days 1 and 3 to healthy adult subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: Verdinexor Other: Placebo Phase 1

Detailed Description:

This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on days 1 and 3 to healthy adult subjects.

Cohorts of 8 subjects each (6 active, 2 placebo) will be sequentially administered verdinexor or placebo (one dose on Day 1 and one dose on Day 3) using a dose-escalation scheme. A conservative, sequential, dose-escalation strategy employing decreasing escalation increments will be used.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Escalating Trial to Evaluate the Safety and Tolerability of Oral Verdinexor (KPT-335) in Healthy Adult Subjects
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: Cohort 1
5 mg verdinexor on Days 1 and 3 or Placebo
Drug: Verdinexor
Other Name: KPT-335

Other: Placebo
Experimental: Cohort 2
10 mg verdinexor on Days 1 and 3
Drug: Verdinexor
Other Name: KPT-335

Experimental: Cohort 3
20 mg verdinexor on Days 1 and 3
Drug: Verdinexor
Other Name: KPT-335

Experimental: Cohort 4
40 mg verdinexor on Days 1 and 3
Drug: Verdinexor
Other Name: KPT-335

Experimental: Cohort 5
60 mg verdinexor on Days 1 and 3
Drug: Verdinexor
Other Name: KPT-335

Experimental: Cohort 6
80 mg verdinexor on Days 1 and 3
Drug: Verdinexor
Other Name: KPT-335

Experimental: Cohort 7
100 mg verdinexor on Days 1 and 3
Drug: Verdinexor
Other Name: KPT-335




Primary Outcome Measures :
  1. Safety and tolerability measured by incidence of adverse events [ Time Frame: 46 days ]
    Safety and tolerability will be evaluated through treatment emergent adverse events (TEAEs), physical examinations, vital signs, electrocardiograms (ECGs), supportive care medications, and changes in laboratory parameters (chemistry, hematology, and urinalysis).


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 46 days ]
  2. Maximum Tolerated Dose (MTD) Determination [ Time Frame: 46 days ]
  3. Area under the curve from 0 to 24 hours post-dose (AUC(0-24) [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be in good health as determined by the investigator, based on the medical history, ECG, physical examination, and safety laboratory tests at screening.
  • Subjects must be identified as a non-smoker at the screening visit (a non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to the screening visit and who has a ≤ 15 pack year history of lifetime cigarette use). A urine cotinine test will be performed at screening and at the time of clinic check-in prior to study drug treatment.

Exclusion Criteria:

  • The subject has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug such as gastrectomy, Crohn's disease, or liver disease.
  • The subject has a history of clinically significant allergies. Hay fever is allowed unless it is active or has required treatment within the previous 2 months.
  • Presence of a chronic condition(s) with clinical or historical evidence of recent exacerbation, or other information to suggest non-control of such condition(s).
  • History of alcohol abuse or drug addiction within 12 months of the screening visit.
  • Any subject with active cataracts or medical history of cataracts.

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): NCT02431364


Locations
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Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
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Principal Investigator: Jason Lickliter, MD Nucleus Network

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Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02431364     History of Changes
Other Study ID Numbers: KCP-335-701
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Karyopharm Therapeutics Inc:
KPT-335
Verdinexor
Karyopharm
First-in-Human
Adult Subjects