Healthy ParticipantsPhase 1NCT05068466
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INCB054707
A Phase 1 study testing INCB054707 in people with Healthy Participants, run by Incyte Biosciences Japan GK at 1 site in Japan.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded, Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses of INCB054707 in healthy male Japanese participants. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- INCB054707
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 21 Oct 2021to 25 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male healthy Japanese adult participants aged 20 to 55 years with a minimum weight of 48 kg.
- Body mass index between 18.0 and 30.5 kg/m2.
- No clinically significant findings in screening evaluations.
- Ability to swallow and retain oral medication.
- Willingness to avoid fathering children
Who cannot join
- History of clinically significant cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease.
- History of rheumatologic/autoimmune disorders, except for minor eczema and rosacea.
- Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.
- History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant.
- Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
- Hemoglobin, WBC, platelet, or ANC that is out of the laboratory's range unless considered clinically insignificant by the investigator at screening or check-in.
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- History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin.
- Current or recent (within 6 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy, excluding appendectomy) that could affect the absorption of study drug.
- Any major surgery within 6 months of screening.
- 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 donation).
- Blood transfusion within 4 weeks of check-in.
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment
- Positive test for HIV and known active HBV or HCV infection or risk of reactivation of HBV or HCV.
- History of alcoholism within 3 months of screening.
- Positive breath or urine test for ethanol or positive urine screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
- 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 study.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with an inducer or inhibitor of CYP3A4, P-gp, or BCRP
- Current use of prohibited medication
- Consumption of Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 72 hours before the first dose of study drug.
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- Known hypersensitivity or severe reaction to INCB054707 or any excipients of INCB054707
- Inability to undergo venipuncture or tolerate venous access.
- Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
- History of tobacco- or nicotine-containing product use within 1 month of screening.
- Use of prescription drugs within 14 days of study drug administration or nonprescription medications/products within 7 days of study drug administration.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study.
- Positive syphilis test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB054707 When Administered Orally to Healthy Japanese Participants
This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded, Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses of INCB054707 in healthy male Japanese participants. Participants in each cohort will be divided into placebo or INCB054707 by a 3:1 INCB054707:placebo random assignment.
- Conditions
- Healthy Participants
- Being tested
- INCB054707, Placebo
- Keywords
- INCB054707
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB054707Drug
Also called Povorcitinib
Administered Orally
PlaceboDrug
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| INCB054707 (Dose A) | Experimental | Participants will be administered single-dose INCB054707 on Day 1 followed by once daily dose of INCB054707 on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours Receives: Drug: INCB054707 |
| INCB054707 (Dose B) | Experimental | Participants will be administered a single-dose INCB054707 on Day 1 followed by once daily dose of INCB54707 on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours. Receives: Drug: INCB054707 |
| Placebo (Dose A) | Placebo comparator | Participants will be administered single-dose placebo on Day 1 followed by once daily dose of placebo on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours Receives: Drug: Placebo |
| Placebo (Dose B) | Placebo comparator | Participants will be administered single-dose placebo on Day 1 followed by once daily dose of placebo on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment Emergent Adverse Events (TEAE'S)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Measured: 3 months
Pharmacokinetics Parameter : Cmax of INCB054707
Maximum Observed Plasma Concentration of INCB054707
Measured: 17 Days
Pharmacokinetics Parameter : Cmin of INCB054707
Minimum Observed Plasma Concentration of INCB054707
Measured: 17 Days
Pharmacokinetics Parameter : tmax of INCB054707
Time to reach maximum plasma concentration of INCB054707
Measured: 17 Days
Pharmacokinetics Parameter : AUC(0-t) of INCB054707
Area Under the concentration- time curve up to the last measurable concentration of INCB054707
Measured: 17 Days
Pharmacokinetics Parameter : AUC(0-∞) of INCB054707
Area Under the Concentration-time Curve From 0 to Infinity of INCB054707
Measured: 17 Days
Pharmacokinetics Parameter : AUC(0-tau) of INCB054707
Area under the single-dose or steady-state plasma concentration-time curve from hour 0 to the end of the dosing period of INCB054707
Measured: 17 Days
Secondary outcomes (5)
Pharmacokinetics Parameter : t1/2 of INCB054707
Pharmacokinetics Parameter : t1/2 of Apparent terminal phase disposition half-life of
Measured: 17 Days
Pharmacokinetics Parameter : CL/F of INCB054707
Oral dose clearance of INCB054707
Measured: 17 Days
Pharmacokinetics Parameter : Vz/F of INCB054707
Apparent oral dose volume of distribution of INCB54707
Measured: 17 Days
Pharmacokinetics Parameter : Cavg of INCB054707
Average plasma concentration at steady state of INCB054707
Measured: 17 Days
Pharmacokinetics Parameter : λz of INCB054707
Apparent terminal-phase disposition rate constant of INCB054707
Measured: 17 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start21 Oct 2021
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Biosciences Japan GK
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068466
- Sponsor's protocol ID
- INCB 54707-108
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB054707 When Administered Orally to Healthy Japanese Participants
- ClinicalTrials.gov ID
- NCT05068466
- Acronym / sponsor ID
- INCB 54707-108
- Conditions
- Healthy Participants
- Keywords
- INCB054707
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Incyte Biosciences Japan GKIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded, Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses of INCB054707 in healthy male Japanese participants. Participants in each cohort will be divided into placebo or INCB054707 by a 3:1 INCB054707:placebo random assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| INCB054707 (Dose A) | Experimental | Drug: INCB054707Participants will be administered single-dose INCB054707 on Day 1 followed by once daily dose of INCB054707 on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours |
| INCB054707 (Dose B) | Experimental | Drug: INCB054707Participants will be administered a single-dose INCB054707 on Day 1 followed by once daily dose of INCB54707 on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours. |
| Placebo (Dose A) | Placebo comparator | Drug: PlaceboParticipants will be administered single-dose placebo on Day 1 followed by once daily dose of placebo on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours |
| Placebo (Dose B) | Placebo comparator | Drug: PlaceboParticipants will be administered single-dose placebo on Day 1 followed by once daily dose of placebo on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male healthy Japanese adult participants aged 20 to 55 years with a minimum weight of 48 kg.
- Body mass index between 18.0 and 30.5 kg/m2.
- No clinically significant findings in screening evaluations.
- Ability to swallow and retain oral medication.
- Willingness to avoid fathering children
Key exclusion criteria (27 listed)
- History of clinically significant cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease.
- History of rheumatologic/autoimmune disorders, except for minor eczema and rosacea.
- Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.
- History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant.
- Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB054707Also: PovorcitinibAdministered Orally | Drug | INCB054707 (Dose A), INCB054707 (Dose B) |
| PlaceboAdministered Orally | Drug | Placebo (Dose A), Placebo (Dose B) |
Primary outcome
Number of participants with Treatment Emergent Adverse Events (TEAE'S)
Time frame: 3 months
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Pharmacokinetics Parameter : Cmax of INCB054707
Time frame: 17 Days
Maximum Observed Plasma Concentration of INCB054707
Pharmacokinetics Parameter : Cmin of INCB054707
Time frame: 17 Days
Minimum Observed Plasma Concentration of INCB054707
Pharmacokinetics Parameter : tmax of INCB054707
Time frame: 17 Days
Time to reach maximum plasma concentration of INCB054707
Pharmacokinetics Parameter : AUC(0-t) of INCB054707
Time frame: 17 Days
Area Under the concentration- time curve up to the last measurable concentration of INCB054707
Pharmacokinetics Parameter : AUC(0-∞) of INCB054707
Time frame: 17 Days
Area Under the Concentration-time Curve From 0 to Infinity of INCB054707
Pharmacokinetics Parameter : AUC(0-tau) of INCB054707
Time frame: 17 Days
Area under the single-dose or steady-state plasma concentration-time curve from hour 0 to the end of the dosing period of INCB054707
5 secondary outcomes
Pharmacokinetics Parameter : t1/2 of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : CL/F of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : Vz/F of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : Cavg of INCB054707
Time frame: 17 Days
Pharmacokinetics Parameter : λz of INCB054707
Time frame: 17 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB054707 in people with Healthy Participants, run by Incyte Biosciences Japan GK at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment Emergent Adverse Events (TEAE'S) (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.