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

NCT02431364 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-01-20

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Verdinexor

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-26
Primary Completion
2015-10-01
Completion
2015-10-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431364 on ClinicalTrials.gov