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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02431364




Registration number
NCT02431364
Ethics application status
Date submitted
22/04/2015
Date registered
1/05/2015
Date last updated
20/01/2023

Titles & IDs
Public title
Trial of Safety and Tolerability of Oral Verdinexor (KPT-335) in Healthy Adults
Scientific 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
Secondary ID [1] 0 0
KCP-335-701
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Verdinexor
Other interventions - Placebo

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

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

Experimental: Verdinexor 10 mg - Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.

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

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


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

Other interventions: Placebo
Participants received placebo matched to verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timepoint [1] 0 0
From start of study drug administration up to Day 33
Secondary outcome [1] 0 0
Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Verdinexor
Timepoint [1] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [2] 0 0
Area Under the Concentration-time Curve From Time Zero to Extrapolated to Infinity (AUC0-inf) of Verdinexor
Timepoint [2] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [3] 0 0
Maximum Observed Concentration (Cmax) of Verdinexor
Timepoint [3] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [4] 0 0
Average Plasma Concentration From Time Zero to 24 Hours Post-dose (Cavg0-24h) of Verdinexor
Timepoint [4] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours post-dose
Secondary outcome [5] 0 0
Time of First Observation of Maximum Observed Concentration (Tmax) of Verdinexor
Timepoint [5] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [6] 0 0
Elimination Rate Constant (Kel) of Verdinexor
Timepoint [6] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [7] 0 0
Elimination Half-life (t1/2) of Verdinexor
Timepoint [7] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [8] 0 0
Apparent Total Body Clearance (Cl/F) of Verdinexor
Timepoint [8] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [9] 0 0
Apparent Volume of Distribution (Vd/F) of Verdinexor
Timepoint [9] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [10] 0 0
Accumulation Factor (AR) of Cmax
Timepoint [10] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [11] 0 0
Accumulation Factor (AR) of Cavg0-24Hour
Timepoint [11] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours post-dose
Secondary outcome [12] 0 0
Accumulation Factor (AR) of AUC0-t
Timepoint [12] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [13] 0 0
Accumulation Factor (AR) of AUC0-inf
Timepoint [13] 0 0
Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose
Secondary outcome [14] 0 0
Maximum Tolerated Dose (MTD) of Verdinexor
Timepoint [14] 0 0
From start of study drug administration up to Day 8

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Karyopharm Therapeutics Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02431364