Trial Outcomes & Findings for Trial of Safety and Tolerability of Oral Verdinexor (KPT-335) in Healthy Adults (NCT NCT02431364)

Last Updated: 2023-01-20

Results Overview

An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur after participant's signed informed consent obtained. A serious adverse event (SAE) was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) that and regardless of causality that: results in death, was life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 30 days following last dose or any event considered drug-related by the investigator through the end of the study.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

33 participants

Primary outcome timeframe

From start of study drug administration up to Day 33

Results posted on

2023-01-20

Participant Flow

This study was conducted at single site in Australia from 26 May 2015 to 1 October 2015.

A total of 33 participants were enrolled and randomized, of which 1 participant randomized to verdinexor 20 milligrams (mg) arm discontinued the study before the start of the treatment (due to Adverse event \[AE\] prior to the pre-dose assessment). Total 32 participants started the study treatment.

Participant milestones

Participant milestones
Measure	Placebo Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg Participants received verdinexor 5 milligrams (mg) (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Overall Study STARTED	8	6	6	7	6
Overall Study Treated	8	6	6	6	6
Overall Study COMPLETED	8	5	6	6	6
Overall Study NOT COMPLETED	0	1	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg Participants received verdinexor 5 milligrams (mg) (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Overall Study Adverse Event	0	1	0	0	0
Overall Study Randomized but never treated	0	0	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=8 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg n=6 Participants Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.	Total n=32 Participants Total of all reporting groups
Age, Continuous	27.0 Years STANDARD_DEVIATION 3.93 • n=5 Participants	24.0 Years STANDARD_DEVIATION 3.35 • n=7 Participants	26.5 Years STANDARD_DEVIATION 1.64 • n=5 Participants	26.3 Years STANDARD_DEVIATION 6.09 • n=4 Participants	27.8 Years STANDARD_DEVIATION 4.07 • n=21 Participants	26.4 Years STANDARD_DEVIATION 4.00 • n=10 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	22 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	10 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	30 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race/Ethnicity, Customized Race · White	7 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	26 Participants n=10 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants

PRIMARY outcome

Timeframe: From start of study drug administration up to Day 33

Population: Safety population included all participants who received at least 1 dose of verdinexor or placebo.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg n=6 Participants Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Participants with TEAEs	5 Participants	6 Participants	3 Participants	4 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Participants with TESAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Population: Pharmacokinetic (PK) population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the limit of quantification \[LOQ\]) post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points.

AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Verdinexor Day 1	215 nanogramhour per milliliter (ngh/mL) Standard Deviation 34.2	445 nanogramhour per milliliter (ngh/mL) Standard Deviation 69.9	862 nanogramhour per milliliter (ngh/mL) Standard Deviation 129.6	1,856 nanogramhour per milliliter (ngh/mL) Standard Deviation 343.9	—
Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Verdinexor Day 3	196 nanogramhour per milliliter (ngh/mL) Standard Deviation 34.3	440 nanogramhour per milliliter (ngh/mL) Standard Deviation 103.4	991 nanogramhour per milliliter (ngh/mL) Standard Deviation 218.1	2,072 nanogramhour per milliliter (ngh/mL) Standard Deviation 521.6	—

SECONDARY outcome

Timeframe: 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

Population: PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points.

AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated). It was calculated as AUC0-t + Ct/kel, where: Ct = the last observed non-zero concentration, kel = elimination rate constant.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Area Under the Concentration-time Curve From Time Zero to Extrapolated to Infinity (AUC0-inf) of Verdinexor Day 1	235 ng*h/mL Standard Deviation 34.3	499 ng*h/mL Standard Deviation 75.1	991 ng*h/mL Standard Deviation 145.0	2,137 ng*h/mL Standard Deviation 371.0	—
Area Under the Concentration-time Curve From Time Zero to Extrapolated to Infinity (AUC0-inf) of Verdinexor Day 3	218 ng*h/mL Standard Deviation 31.6	491 ng*h/mL Standard Deviation 104.8	1,052 ng*h/mL Standard Deviation 217.6	2,141 ng*h/mL Standard Deviation 539.4	—

SECONDARY outcome

Timeframe: 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

Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Maximum Observed Concentration (Cmax) of Verdinexor Day 1	27.8 nanogram per milliliter (ng/mL) Standard Deviation 7.48	65.0 nanogram per milliliter (ng/mL) Standard Deviation 12.13	122 nanogram per milliliter (ng/mL) Standard Deviation 26.3	212 nanogram per milliliter (ng/mL) Standard Deviation 81.6	—
Maximum Observed Concentration (Cmax) of Verdinexor Day 3	24.8 nanogram per milliliter (ng/mL) Standard Deviation 5.42	56.2 nanogram per milliliter (ng/mL) Standard Deviation 12.94	116 nanogram per milliliter (ng/mL) Standard Deviation 36.9	252 nanogram per milliliter (ng/mL) Standard Deviation 74.6	—

SECONDARY outcome

Timeframe: Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours post-dose

Cavg0-24h was defined as average plasma concentration from time zero to 24 hours post-dose.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Average Plasma Concentration From Time Zero to 24 Hours Post-dose (Cavg0-24h) of Verdinexor Day 1	8.35 ng/mL Standard Deviation 1.835	19.6 ng/mL Standard Deviation 2.71	42.3 ng/mL Standard Deviation 9.97	72.4 ng/mL Standard Deviation 25.63	—
Average Plasma Concentration From Time Zero to 24 Hours Post-dose (Cavg0-24h) of Verdinexor Day 3	8.73 ng/mL Standard Deviation 3.281	17.3 ng/mL Standard Deviation 4.91	44.4 ng/mL Standard Deviation 9.05	86.7 ng/mL Standard Deviation 29.56	—

SECONDARY outcome

Timeframe: 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

Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Time of First Observation of Maximum Observed Concentration (Tmax) of Verdinexor Day 1	3.0 hours Interval 2.0 to 4.0	4.0 hours Interval 2.0 to 4.0	3.0 hours Interval 2.0 to 4.0	4.0 hours Interval 2.0 to 4.0	—
Time of First Observation of Maximum Observed Concentration (Tmax) of Verdinexor Day 3	3.0 hours Interval 2.0 to 4.0	3.0 hours Interval 3.0 to 4.0	3.0 hours Interval 2.0 to 4.0	3.0 hours Interval 2.0 to 4.0	—

SECONDARY outcome

Timeframe: 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

Population: PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ) post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points.

Elimination rate constant was calculated using linear regression on the terminal portion of the log-linear concentration versus time curve.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Elimination Rate Constant (Kel) of Verdinexor Day 3	0.103 per hour (1/h) Standard Deviation 0.0282	0.087 per hour (1/h) Standard Deviation 0.0218	0.090 per hour (1/h) Standard Deviation 0.0381	0.093 per hour (1/h) Standard Deviation 0.0215	—
Elimination Rate Constant (Kel) of Verdinexor Day 1	0.113 per hour (1/h) Standard Deviation 0.0314	0.091 per hour (1/h) Standard Deviation 0.0227	0.082 per hour (1/h) Standard Deviation 0.0177	0.097 per hour (1/h) Standard Deviation 0.0306	—

SECONDARY outcome

Timeframe: 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

t1/2 was defined as elimination half-life, it was calculated as ln(2)/kel.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Elimination Half-life (t1/2) of Verdinexor Day 1	6.6 hours Standard Deviation 1.97	8.0 hours Standard Deviation 1.99	9.0 hours Standard Deviation 2.68	7.8 hours Standard Deviation 2.54	—
Elimination Half-life (t1/2) of Verdinexor Day 3	7.3 hours Standard Deviation 2.85	8.3 hours Standard Deviation 1.91	8.7 hours Standard Deviation 2.97	7.7 hours Standard Deviation 1.76	—

SECONDARY outcome

Timeframe: 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

Apparent total body clearance was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram \[kg\]).

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Apparent Total Body Clearance (Cl/F) of Verdinexor Day 1	0.32 liter per hour per kilogram (L/h/kg) Standard Deviation 0.075	0.30 liter per hour per kilogram (L/h/kg) Standard Deviation 0.023	0.31 liter per hour per kilogram (L/h/kg) Standard Deviation 0.057	0.32 liter per hour per kilogram (L/h/kg) Standard Deviation 0.040	—
Apparent Total Body Clearance (Cl/F) of Verdinexor Day 3	0.35 liter per hour per kilogram (L/h/kg) Standard Deviation 0.068	0.30 liter per hour per kilogram (L/h/kg) Standard Deviation 0.039	0.30 liter per hour per kilogram (L/h/kg) Standard Deviation 0.059	0.33 liter per hour per kilogram (L/h/kg) Standard Deviation 0.102	—

SECONDARY outcome

Timeframe: 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

Vd/F was calculated as Dose/ (kel \*AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kg).

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Apparent Volume of Distribution (Vd/F) of Verdinexor Day 1	3.0 liter per kilogram (L/kg) Standard Deviation 0.96	3.4 liter per kilogram (L/kg) Standard Deviation 0.89	3.9 liter per kilogram (L/kg) Standard Deviation 0.52	3.5 liter per kilogram (L/kg) Standard Deviation 1.01	—
Apparent Volume of Distribution (Vd/F) of Verdinexor Day 3	3.6 liter per kilogram (L/kg) Standard Deviation 1.13	3.6 liter per kilogram (L/kg) Standard Deviation 0.46	3.6 liter per kilogram (L/kg) Standard Deviation 0.90	3.7 liter per kilogram (L/kg) Standard Deviation 1.72	—

SECONDARY outcome

Timeframe: 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

Population: PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here 'number analyzed' signifies number of participants evaluable at specific time points.

An AR was defined as a ratio of mean of Cmax Day 3/ Cmax Day 1 for plasma verdinexor.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Accumulation Factor (AR) of Cmax	0.9 Ratio	0.9 Ratio	0.9 Ratio	1.2 Ratio	—

SECONDARY outcome

Timeframe: Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours post-dose

Population: PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here 'number analyzed' signifies number of participants evaluable at specific time points.

An AR was defined as a ratio of mean of Cavg0-24hour Day 3/ Cavg0-24hour Day 1 for plasma verdinexor.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Accumulation Factor (AR) of Cavg0-24Hour	1.0 Ratio	0.9 Ratio	1.1 Ratio	1.2 Ratio	—

SECONDARY outcome

Timeframe: 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

Population: PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here 'number analyzed' signifies number of participants evaluable at specific time points.

An AR factor was defined as a ratio of mean of AUC0-t Day 3/ AUC0-t Day 1 for plasma verdinexor.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Accumulation Factor (AR) of AUC0-t	0.9 Ratio	1.0 Ratio	1.1 Ratio	1.1 Ratio	—

SECONDARY outcome

Timeframe: 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

Population: PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here 'number analyzed' signifies number of participants evaluable at specific time points.

Accumulation factor was defined as a ratio of mean of AUC0-inf Day 3/ AUC0-inf Day 1 for plasma verdinexor.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 Participants Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 Participants Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 Participants Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Accumulation Factor (AR) of AUC0-inf	0.9 Ratio	1.0 Ratio	1.1 Ratio	1.0 Ratio	—

SECONDARY outcome

Timeframe: From start of study drug administration up to Day 8

Population: MTD was not achieved at study completion due to early termination of study prior to observing protocol-specified DLT criteria. Therefore, no data was reported for this outcome measure.

MTD was defined as the dose level tested in the cohort immediately preceding a cohort where one or more dose limiting toxicities (DLTs) were observed. A DLT was defined as any AE or abnormal laboratory value that the Investigator suspected was probably related to verdinexor that was severe in intensity or serious or Indicative of an unacceptable risk to additional participants in the study in the opinion of the Investigator or Sponsor.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Verdinexor 5 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Verdinexor 10 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Verdinexor 20 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Verdinexor 40 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=8 participants at risk Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3.	Verdinexor 5 mg n=6 participants at risk Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3.	Verdinexor 10 mg n=6 participants at risk Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3.	Verdinexor 20 mg n=6 participants at risk Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3.	Verdinexor 40 mg n=6 participants at risk Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Cardiac disorders Palpitations	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Gastrointestinal disorders Abdominal discomfort	12.5% 1/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	33.3% 2/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Gastrointestinal disorders Nausea	12.5% 1/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	33.3% 2/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	66.7% 4/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Gastrointestinal disorders Toothache	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Gastrointestinal disorders Vomiting	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
General disorders Chills	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Infections and infestations Nasopharyngitis	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Investigations Spermatozoa morphology abnormal	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Investigations Spermatozoa progressive motility decreased	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Nervous system disorders Dizziness	25.0% 2/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Nervous system disorders Dizziness postural	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Nervous system disorders Headache	12.5% 1/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	33.3% 2/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	33.3% 2/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	33.3% 2/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Nervous system disorders Lethargy	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	50.0% 3/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Nervous system disorders Somnolence	12.5% 1/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Nervous system disorders Syncope	12.5% 1/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Psychiatric disorders Insomnia	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Reproductive system and breast disorders Dysmenorrhoea	12.5% 1/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.
Vascular disorders Phlebitis	0.00% 0/8 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	16.7% 1/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.	0.00% 0/6 • From start of study drug administration up to Day 33 Safety population included all participants who received at least 1 dose of verdinexor or placebo.

Additional Information

Jatin Shah, MD

Karyopharm Therapeutics Inc

Phone: (617) 658-0600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place