A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Dose Escalation, and Food-Effect Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally to Healthy Adult Participants
Overview
- Phase
- Phase 1
- Intervention
- INCB000631
- Conditions
- Not specified
- Sponsor
- Incyte Corporation
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- PK for plasma INCB000631: Cmax
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
This study will be conducted to assess the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally to Healthy Adult Participants.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Aged 19 to 55 years, inclusive, at the time of signing the ICF.
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled with a body mass index \> 30 to ≤ 32.0 kg/m
- •No clinically significant findings on screening evaluations (clinical, laboratory \[except lipids\], and ECG) as determined by the investigator. If the investigator has questions about clinically significant findings, the medical monitor should be consulted.
- •Ability to swallow and retain oral tablets.
- •Willingness to avoid pregnancy or fathering children based on the protocol defined criteria.
Exclusion Criteria
- •History of uncontrolled or unstable respiratory, renal, gastrointestinal, endocrine, pulmonary, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- •History of an autoimmune disease (eg, myasthenia gravis).
- •History of cardiovascular, cerebrovascular, cerebral, peripheral vascular, or thrombotic disease or uncontrolled hypertension.
- •High blood pressure (systolic blood pressure \> 140 mm Hg or diastolic blood pressure \> 90 mm Hg at screening, confirmed by repeat testing).
- •Confirmed resting pulse (up to 3 measurements) \< 40 bpm or \> 100 bpm at screening for vital signs.
- •History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant. Participants with a QTcF interval \> 450 milliseconds (males) or \> 470 milliseconds (females), QRS interval \> 120 milliseconds, or PR interval \> 220 milliseconds will be excluded.
- •In the event a value is exclusionary, a single ECG will be repeated twice, and an average of the 3 readings will be used to determine if a participant should be excluded.
- •Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
- •History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
- •History of other malignancy within 2 years of screening (with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy) or cancers from which the participant has been disease-free for \< 1 year after treatment with curative intent.
Arms & Interventions
Cohort A
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: INCB000631
Cohort A
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: Placebo
Cohort B
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: INCB000631
Cohort B
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: Placebo
Cohort C
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: INCB000631
Cohort C
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: Placebo
Cohort D
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: INCB000631
Cohort D
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: Placebo
Cohort E
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: INCB000631
Cohort E
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: Placebo
Optional Cohort F
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: INCB000631
Optional Cohort F
INCB000631 or placebo will be administered at the protocol defined dose.
Intervention: Placebo
Cohort G Treatment A
INCB000631 will be administered at the protocol defined dose.
Intervention: INCB000631
Cohort G Treatment B
INCB000631 will be administered at the protocol defined dose.
Intervention: INCB000631
Outcomes
Primary Outcomes
PK for plasma INCB000631: Cmax
Time Frame: Up to Day 14
Maximum Observed Plasma Concentration of INCB000631.
PK for plasma INCB000631: tmax
Time Frame: Up to Day 14
Time to maximum plasma concentration of INCB000631.
PK for plasma INCB000631: AUC 0-∞
Time Frame: Up to Day 14
Area under the single-dose plasma concentration-time curve from 0 to Infinity of INCB000631.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Day 41
Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after dose of study treatment.
PK for plasma INCB000631: AUC(0-t)
Time Frame: Up to Day 14
Area under the single-dose plasma concentration-time curve up to the last measurable plasma concentration of INCB000631.
Secondary Outcomes
- PK for plasma INCB000631: t1/2(Up to Day 14)
- PK for plasma INCB000631: CL/F(Up to Day 14)
- PK for urine INCB000631: Ae96h(Up to Day 14)
- PK for plasma INCB000631: Vz/F(Up to Day 14)
- PK for urine INCB000631: fe(Up to Day 14)
- PK for urine INCB000631: CLR(Up to Day 14)
- PK for plasma INCB000631: λz(Up to Day 14)