Conditions: Healthy
Keywords: KPT-335 Verdinexor Karyopharm First-in-Human Adult Subjects
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 33
Healthy volunteers: yes

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.

Arms:
arm 1: Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3. arm 2: Participants received verdinexor 5 milligrams (mg) (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3. arm 3: Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3. arm 4: Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3. arm 5: Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.

Interventions: intervention 1: Verdinexor intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral intervention 2: Participants received placebo matched to verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral

Protocol document: