Recent Updates
Recently added Catalysts

AB-106, digoxin

Phase 1

Solid Tumor | Small molecule | Oncology |Nuvation Bio Inc.|Last Updated: Nov 21, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials2
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05357820A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PKPHASE1 COMPLETED 56Jul 19, 2021Dec 3, 2021Nov 21, 20241 China
NCT05357911A Study on the Effect of AB-106 on the Pharmacokinetics of DigoxinPHASE1 COMPLETED 16Jul 13, 2021Dec 3, 2021Nov 21, 20241 China
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
AB-106 PK Exposure Parameters
29 days

Peak Plasma Concentration (Cmax)

The PK exposure parameters of digoxin
17 days

Area under the plasma concentration versus time curve (AUC)

Secondary Endpoints
AB-106 PK Parameters
29 days
Safety Assessment
47 days
The PK parameters of digoxin
17 days
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Itraconazole cohortEXPERIMENTAL -
Rifampicin cohortEXPERIMENTAL -
digoxin cohortEXPERIMENTAL -
Interventions
NameTypeDescription
AB-106, ItraconazoleDRUGsingle dose AB-106 at Day1, Itraconazole QD at Day14\~Day28, single dose AB-106 at Day17
AB-106, RifampicinDRUGsingle dose AB-106 at Day1, Itraconazole QD at Day14\~Day32, single dose AB-106 at Day21
AB-106, digoxinDRUGPeriod 1, single dose of 0.25mg digoxin; Period 2, Coadministrate AB-106 600mg and 0.25mg digoxin
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. The subject is willing to give written informed consent. 2. The subject is capable to communicate well with investigator and comply with comply with protocol throughout the study. 3. Aged between 18 to 55 at giving written informed consent. 4. Chinese male healthy subjects (N...

Countries:China
Unlock Eligibility Criteria