NCT02431364

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-05-26
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-05-01
• Last updated: 2023-01-20
• Results posted: 2021-04-13

Locations

1 site across 1 country: Australia