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Trial registered on ANZCTR


Registration number
ACTRN12621000103864
Ethics application status
Approved
Date submitted
8/12/2020
Date registered
2/02/2021
Date last updated
2/02/2021
Date data sharing statement initially provided
2/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
To assess the safety, tolerability and pharmacokinetics of INCB86550 in healthy adult population.
Scientific title
A Phase 1, randomized, drug-interaction, and food effect study to assess the safety, tolerability, and pharmacokinetics of INCB086550 when administered orally to healthy adult participants.
Secondary ID [1] 302928 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 319946 0
Condition category
Condition code
Cancer 317882 317882 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INCB086550 is an oral tablet administered in healthy adult participants in combination with food, esomeprazole, famotidine, itraconazole and rifampin. In Cohort 1, all participants will receive the same dose of INCB086550 in both a fasted and a fed state. In Cohort 2-5, all participants will receive the same dose of INCB086550 alone or with interacting drug in a fasted state.
Cohort 1 - 400 mg of INCB086550 as a single dose administered orally in a fasted or fed condition
Cohort 2 - 400 mg of INCB086550 as a single dose administered orally on Day 1 and 40 mg of Esomeprazole is administered orally on days 5 through 9 and a combination of INCB086550 (400 mg) and Esomeprazole (40 mg) administered on day 8 in fasted conditions.
Cohort 3 - 400 mg of INCB086550 as a single dose administered orally on Day 1 and 20 mg of Famotidine is administered orally on days 5 through 7 and a combination of INCB086550 (400 mg) and Famotidine (20 mg) administered on day 8 in fasted conditions.
Cohort 4 - 200 mg of INCB086550 as a single dose administered orally on Day 1 and 200 mg of Itraconazole is administered orally on days 4 through 7 and a combination of INCB086550 (400 mg) and Itraconazole (200 mg) administered on day 8 in fasted conditions. Itraconazole (200 mg) is administered on days 9 through 11 in fed state.
Cohort 5 - 400 mg of INCB086550 as a single dose administered orally on Day 1 and 600 mg of Rifampin is administered orally on days 4 through 10 and a combination of INCB086550 (400 mg) and Rifampin (600 mg) administered on day 11 in fasted conditions. Rifampin (600 mg) is administered on day 12 in fed state.
The study participants are in-house for the duration of the trial, therefore, all dose administrations is managed by the site staff. The site pharmacist will maintain drug accountability logs that record the dose administration for each study participant
Intervention code [1] 319212 0
Treatment: Drugs
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325898 0
To determine the effect of food, esomeprazole, famotidine, itraconazole and rifampin on Cmax, Tmax, AUC0-t and AUC 0-inf of INCB086550. single dose
Timepoint [1] 325898 0
0 h (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 h postdose on day 1 and 8,, 24 and 36 h postdose on days 2 and 9, 48 h postdose on days 3 and 10, 72 h postdose on days 4 and 11, 96 h postdose on days 5 and 12.
Secondary outcome [1] 389467 0
Number of treatment-emergent adverse events with INCB086550 assessed by performing physical examinations and collecting vital signs, 12 lead ECGs and clinical laboratory data. During data analysis all TEAEs will be summarized by descriptive statistics
Timepoint [1] 389467 0
Physical exams will be performed at screening check in and follow up in all cohorts and additionally on Day 7 in the food effect cohort and vital signs will be collected at screening and once a day everyday on confinement and at predose and 12, 24, 48, 72, 96, 120, 144, 168 and 192 hours postdose on first INCB086550 dosing day and at predose and 12, 24, 48, 72, and 96 hours postdose on INCB086550 second dosing day.
ECG will be performed at screening, check in and at -1.5, -1, and -0.5 hours predose and at 1, 2, 4, 6, 8, 12, and 24 hours postdose on INCB86550 dosing days.

Eligibility
Key inclusion criteria
Male or female healthy adult participants aged 18 to 55 years.
Body mass index between 18.0 and 30.5 kg/m2, inclusive.
No clinically significant findings on screening evaluations (clinical, laboratory, and ECG).
Ability to swallow and retain oral medication.
Willingness to avoid pregnancy or fathering children.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
2.History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant. QTcF interval > 450 milliseconds, QRS interval > 120 milliseconds, and PR interval > 220 milliseconds
3.Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy) that could affect the absorption of study drug except that appendectomy will be allowed.
4.Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for plasma only).
5.History of alcoholism within 3 months of screening.
6.Positive urine, blood, or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
7.Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug protocol.
8.History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
9.Use of tobacco- or nicotine-containing products within 1 months of screening.
10.Women who are pregnant or breastfeeding.
11.Any history of hypersensitivity or intolerance to esomeprazole or any other Proton Pump Inhibitor

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/03/2021
Actual
Date of last participant enrolment
Anticipated
26/04/2021
Actual
Date of last data collection
Anticipated
31/05/2021
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307350 0
Commercial sector/Industry
Name [1] 307350 0
Incyte Corporation
Country [1] 307350 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Incyte Corporation
Address
1815 Augustine Cut Off, Wilmington, DE 19803
Country
United States of America
Secondary sponsor category [1] 307989 0
None
Name [1] 307989 0
Address [1] 307989 0
Country [1] 307989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307437 0
Alfred Health Ethics Committee
Ethics committee address [1] 307437 0
The Alfred
55 Commercial Road, Melbourne VIC 3004
Ethics committee country [1] 307437 0
Australia
Date submitted for ethics approval [1] 307437 0
07/12/2020
Approval date [1] 307437 0
08/01/2021
Ethics approval number [1] 307437 0

Summary
Brief summary
The purpose of this study is to assess the safety, tolerability of the drug INCB086550 and assess how this drug acts in the body with and without food and in combination with other drugs.
who is it for?
You may be eligible for this study if you are a male or female, aged 18 to 55, and you are in good health with no existing conditions.
Study Details
In Cohort 1 all participants will receive a single dose of the drug (orally in a fasted (no food) or fed (med calorie food) condition in Periods 1 and 2 by random assignment. In Cohort 2 through 5 subjects will be dosed with INCB086550 in combination with other drugs specified earlier.
It is hoped this research will provide information as to how this drug acts in the body in fed and fasted conditions and in combination with other drugs, results from the study will affect how patients with cancer use this medication
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107234 0
Prof Richard Friend
Address 107234 0
Q-Pharm Pty. Ltd.
Level 5 Clive Berghofer Cancer Centre Research Centre,
300 Herston Road, Herston,
QLD 4006
Country 107234 0
Australia
Phone 107234 0
+61 7 3707 2700
Fax 107234 0
Email 107234 0
[email protected]
Contact person for public queries
Name 107235 0
Richard Friend
Address 107235 0
Q-Pharm Pty. Ltd.
Level 5 Clive Berghofer Cancer Centre Research Centre,
300 Herston Road, Herston,
QLD 4006
Country 107235 0
Australia
Phone 107235 0
+61 7 3707 2700
Fax 107235 0
Email 107235 0
[email protected]
Contact person for scientific queries
Name 107236 0
Richard Friend
Address 107236 0
Q-Pharm Pty. Ltd.
Level 5 Clive Berghofer Cancer Centre Research Centre,
300 Herston Road, Herston,
QLD 4006
Country 107236 0
Australia
Phone 107236 0
+61 7 3707 2700
Fax 107236 0
Email 107236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.