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

NCT ID: NCT02431364

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-26
• Study Completion Date: 2015-10-01

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 participants.

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 participants.

Cohorts of 8 participants 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants received placebo matched to verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral

Verdinexor 5 mg

Participants received verdinexor 5 milligrams (mg) (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.

Group Type: EXPERIMENTAL

Verdinexor

Intervention Type: DRUG

Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral

Verdinexor 10 mg

Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.

Group Type: EXPERIMENTAL

Verdinexor

Intervention Type: DRUG

Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral

Verdinexor 20 mg

Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.

Group Type: EXPERIMENTAL

Verdinexor

Intervention Type: DRUG

Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral

Verdinexor 40 mg

Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.

Group Type: EXPERIMENTAL

Verdinexor

Intervention Type: DRUG

Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral

Interventions

Verdinexor

Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral

Intervention Type: DRUG

Placebo

Participants received placebo matched to verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral

Intervention Type: OTHER

Other Intervention Names

KPT-335

Eligibility Criteria

Inclusion Criteria

• Participants must be in good health as determined by the investigator, based on the medical history, ECG, physical examination, and safety laboratory tests at screening.
• Participants 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 participant 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 participant 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 participant with active cataracts or medical history of cataracts.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karyopharm Therapeutics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nucleus Network

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

KCP-335-701

Identifier Type: -

Identifier Source: org_study_id