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Trial registered on ANZCTR


Registration number
ACTRN12620000118909p
Ethics application status
Submitted, not yet approved
Date submitted
24/01/2020
Date registered
7/02/2020
Date last updated
7/02/2020
Date data sharing statement initially provided
7/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of increasing oral doses of INCB099318 in healthy adult participants, and the effect of food on pharmacokinetics.
Scientific title
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single Dose, Dose-Escalation and Food-Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB099318 When Administered Orally to Healthy Adult Participants
Secondary ID [1] 300278 0
INCB99318-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 315859 0
Condition category
Condition code
Cancer 314138 314138 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INCB099318 is an oral tablet administered after a fast of 8 hrs in cohorts 1 through 5. In Cohort 6 subjects will be randomly assigned to treatment A or treatment B groups. Subjects in treatment A group will be dosed after fasting of 8 hrs. Subjects in treatment B group will be fed a high-fat calorie meal 30 min before dose administration. Participants will be admitted to the clinic on the day -1 before study drug administration and confined through 96 hours after the dosing. In Cohort 6 subjects will return on Day 7 for admission and receive another dose of the drug on Day 8 and be confined through 96 hours after dosing.
Cohort 1 - 20 mg of INCB099318 or Placebo as a single dose administered orally in a fasted condition
Cohort 2 – up to 40 mg of INCB099318 or Placebo as a single dose administered orally in a fasted condition
Cohort 3 – up to 80 mg of INCB099318 or Placebo as a single dose administered orally in a fasted condition
Cohort 4 - up to 160 mg of INCB099318 or Placebo as a single dose administered orally in a fasted condition
Cohort 5 – up to 320 mg of I INCB099318 or Placebo as a single dose administered orally in a fasted condition
Cohort 6 – up to 160mg of INCB099318 in Fasted or Fed conditions as a single dose administered orally
Intervention code [1] 316551 0
Treatment: Drugs
Comparator / control treatment
Placebo tablets have been developed to match the INCB099318 20 mg and 100 mg tablets and are similar in appearance to the active drug product tablets with regard to color, size, and shape, and contain microcrystalline cellulose, mannitol, crospovidone, silicon dioxide, and magnesium stearate. The placebo tablets will also be coated with a nonfunctional white film coat.
Control group
Placebo

Outcomes
Primary outcome [1] 322527 0
Number of treatment-emergent adverse events with INCB099318.
As this is the first clinical study of INCB099318, the safety profile in humans has not been established, possible symptoms or adverse effects that could occur may be immune-related effects such as inflammation of the skin or mucosa (for example, itching, redness, rash), inflammation of the lungs, inflammation of the bowels (for example, diarrhea), endocrine (hormone) dysfunction, liver injury, and fatigue or lack of energy. AE's will be assessed by clinical examination and self reporting.
Timepoint [1] 322527 0
Baseline to 30 days after last dose
Primary outcome [2] 322528 0
Pharmacokinetic (PK) evaluation of INCB099318 (Cmax, Tmax, AUC0-t and AUC 0-inf) in the fasted state in plasma samples
Timepoint [2] 322528 0
0h (pre dose), 0.5,1,2,4,6,8,12,16,24,36,48, 72, and 96h post dose.
Primary outcome [3] 322529 0
Pharmacokinetic (PK) evaluation of INCB099318 (Cmax, Tmax, AUC0-t and AUC 0-inf) and to determine the effect of food in plasma samples
Timepoint [3] 322529 0
0h (pre dose), 0.5,1,2,4,6,8,12,16,24,36,48, 72, and 96h post dose
Secondary outcome [1] 378838 0
Additional Pharmacokinetic parameter evaluation in Plasma include
t½, CL/F, Vz/F, Lambda-z
Timepoint [1] 378838 0
0h (pre dose), 0.5,1,2,4,6,8,12,16,24,36,48, 72, and 96h post dose
Secondary outcome [2] 378839 0
Pharmacokinetic evaluation of INCB099318 in Urine include
Ae96h and CLR
Timepoint [2] 378839 0
0-8,8-16,16-24,24-36,36-48,48-72, and 72-96 h post dose.

Eligibility
Key inclusion criteria
1. Male or female healthy adult participants aged 18 to 55 years
2. BMI between 18.0 and 30.0 kg/m2, inclusive. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor’s approval.
3. 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.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2020
Actual
Date of last participant enrolment
Anticipated
15/06/2020
Actual
Date of last data collection
Anticipated
10/07/2020
Actual
Sample size
Target
72
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 304702 0
Commercial sector/Industry
Name [1] 304702 0
Incyte Corporation
Country [1] 304702 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] 305014 0
None
Name [1] 305014 0
Address [1] 305014 0
Country [1] 305014 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305120 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 305120 0
The Alfred
55 Commercial Road, Melbourne VIC 3004
Ethics committee country [1] 305120 0
Australia
Date submitted for ethics approval [1] 305120 0
05/02/2020
Approval date [1] 305120 0
Ethics approval number [1] 305120 0

Summary
Brief summary
The purpose of this study is to assess the safety, tolerability of the drug INCB099318 and assess how this drug acts in the body with and without food in increasing doses.
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.
Participants in this study will be randomized (by chance) in each of the 6 cohort. In Cohorts 1-5 all participants will either receive a single dose of the drug or placebo (orally in a fasted condition (no food). In Cohort 6 subjects will be randomly assigned to treatment A or treatment B groups. Subjects in treatment A group will be dosed after fasting for 8 hrs. Subjects in treatment B group will be fed a high-fat calorie meal before 30 min of dose administration. All cohort 6 participants will receive two single doses of drug. Participants will also provide blood and urine samples.
It is hoped this research will provide information as to how this drug acts in the body in fed and fasted conditions, 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 99338 0
Dr Ben Snyder
Address 99338 0
The Alfred
55 Commercial Road, Melbourne VIC 3004
Country 99338 0
Australia
Phone 99338 0
+61 3 9076 8825
Fax 99338 0
Email 99338 0
[email protected]
Contact person for public queries
Name 99339 0
Ben Snyder
Address 99339 0
The Alfred
55 Commercial Road, Melbourne VIC 3004
Country 99339 0
Australia
Phone 99339 0
+61 3 9076 8825
Fax 99339 0
Email 99339 0
[email protected]
Contact person for scientific queries
Name 99340 0
Ben Snyder
Address 99340 0
The Alfred
55 Commercial Road, Melbourne VIC 3004
Country 99340 0
Australia
Phone 99340 0
+61 3 9076 8825
Fax 99340 0
Email 99340 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
There is no plan to share IPD


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.