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Healthy ParticipantsPhase 1NCT06416800

A Study to Assess the Effect of Povorcitinib on Digoxin, Rosuvastatin, and Metformin Pharmacokinetics and the Effect of Probenecid on Povorcitinib Pharmacokinetics When Administered Orally to Healthy Adult Participants

A Phase 1 study testing Digoxin, Rosuvastatin and Metformin in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to Assess the Effect of Povorcitinib on Digoxin, Rosuvastatin, and Metformin Pharmacokinetics and the Effect of Probenecid on Povorcitinib Pharmacokinetics When Administered Orally to Healthy Adult Participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Digoxin, Rosuvastatin and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteUnited States
Study dates
19 Jun 2024to 15 Jan 2025
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ability to comprehend and willingness to sign a written ICF for the study.
  • Aged 18 to 55 years, inclusive, at the time of signing the ICF.
  • BMI between 18.0 and 30.5 kg/m2, inclusive. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor's approval.
  • No clinically significant findings on screening evaluations (eg, clinical, laboratory, and ECG evaluations).
  • Ability to swallow and retain oral medication.
  • Willingness to avoid pregnancy or fathering children based on the criteria below:
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  • Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the last dose of study treatment and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
  • Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in on Day -1 and must agree to take appropriate precautions to avoid pregnancy from screening through 30 days (1 menstrual cycle) after the last dose of study treatment and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
  • Female participants not considered to be of childbearing potential are eligible.

Who cannot join

  • History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
  • History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (ie, systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening, confirmed by repeat testing).
  • History or presence of cardiovascular symptoms including but not limited to chest pain or pressure, palpitations, irregular heartbeat, syncope (excluding vasovagal from phlebotomy), dyspnea at rest or on exertion, lightheadedness, orthopnea, or paroxysmal nocturnal dyspnea that is considered clinically significant by the investigator.
  • Resting pulse < 40 bpm or > 100 bpm at screening, confirmed by repeat testing.
  • History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant (ie, a QTcF interval > 450 milliseconds for males and > 470 milliseconds for females, QRS interval > 120 milliseconds, and PR interval > 220 milliseconds).
  • Presence or history of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could affect drug absorption.
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  • Hemoglobin, WBC count, platelet count, or absolute neutrophil count less than the laboratory LLN at screening or check-in, confirmed by repeat testing. Hemoglobin, WBC, platelet, and neutrophil abnormalities must also be clinically significant in the opinion of the investigator to be exclusionary.
  • Vitamin B12, folate, TSH, or parathyroid hormone levels less than the laboratory LLN at screening that are also clinically significant in the opinion of the investigator.
  • ALT, AST, ALP, or total bilirubin > 1.25 × the laboratory-defined ULN at screening or check-in, confirmed by repeat testing (except participants with Gilbert's disease, for whom total bilirubin must be ≤ 2.0 × ULN).
  • History of malignancy within 5 years before screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
  • Current or recent (within 3 months before screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy; excluding appendectomy) that could affect drug absorption.
  • Any major surgery within 4 weeks of screening.
  • Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks before screening (within 2 weeks for plasma-only donation).
  • Blood transfusion within 4 months before check-in (Day -1).
  • Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes latent treated tuberculosis).
  • Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
  • Receipt of live (including attenuated) vaccines within 28 days before the first dose of study treatment or anticipation of need for such a vaccine during the study. Note: Nonlive or inactivated vaccines are allowed up to 2 weeks before the first dose of study treatment.
  • History of significant alcohol use within 3 months before screening.
  • Positive urine 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.
  • Current treatment, or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study treatment, 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 treatment, with an inducer or inhibitor of CYP3A4, P-gp, or BCRP (refer to the Drug Interaction Database [2024] for prohibited drugs).
  • 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 treatment.
  • Current use of prohibited medication.
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
  • Known hypersensitivity or severe reaction to povorcitinib or any excipients of povorcitinib, digoxin, rosuvastatin, metformin or probenecid (refer to the IB and applicable package inserts).
  • Inability to undergo venipuncture or tolerate venous access.
  • History of tobacco- or nicotine-containing product-use within 1 month before screening. However, use of nicotine-containing products prior to screening that is equivalent to ≤ 2 cigarettes per week may be permitted at the discretion of the investigator.
  • Use of prescription drugs (including hormonal contraceptives) within 14 days before study treatment administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days of study treatment administration. However, occasional paracetamol, ibuprofen, and standard-dose multivitamins are permitted.
  • Women who are pregnant or breastfeeding.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • An eGFR < 90 mL/min/1.73 m2, based on the site's standard formula, at screening. A repeat measurement may be allowed at the investigator's discretion.
  • Cohort 4 only: Uric acid levels less than the laboratory LLN at screening or check-in, confirmed by repeat testing.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fortrea Clinical Research Unit

    Dallas, Texas, 75247

Other trials in United States

About this study

Official title: An Open-Label Study to Assess the Effect of Povorcitinib on Digoxin, Rosuvastatin, and Metformin Pharmacokinetics and the Effect of Probenecid on Povorcitinib Pharmacokinetics When Administered Orally to Healthy Adult Participants

The purpose of this study is to Assess the Effect of Povorcitinib on Digoxin, Rosuvastatin, and Metformin Pharmacokinetics and the Effect of Probenecid on Povorcitinib Pharmacokinetics When Administered Orally to Healthy Adult Participants.

Being tested
Digoxin, Rosuvastatin, Metformin, Povorcitinib, Probenecid
Keywords
INCB054707

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DigoxinDrug

    Oral; Tablet

  • RosuvastatinDrug

    Oral; Tablet

  • MetforminDrug

    Oral; Tablet

  • PovorcitinibDrug

    Oral; Tablet

  • ProbenecidDrug

    Oral; Tablet

Study groups in NCT06416800
Study groupRoleWhat they receive
Cohort 1: DoseExperimentalDigoxin and povorcitinib will be administered at protocol defined doses.
Receives: Drug: Digoxin; Drug: Povorcitinib
Cohort 2: DoseExperimentalRosuvastatin and povorcitinib will be administered at protocol defined doses.
Receives: Drug: Rosuvastatin; Drug: Povorcitinib
Cohort 3: DoseExperimentalMetformin and povorcitinib will be administered at protocol defined doses.
Receives: Drug: Metformin; Drug: Povorcitinib
Cohort 4: DoseExperimentalProbenecid and povorcitinib will be administered at protocol defined doses.
Receives: Drug: Povorcitinib; Drug: Probenecid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic (PK) in plasma digoxin

    Digoxin concentration in plasma.

    Measured: Up to Day 15

  2. PK in plasma rosuvastatin

    Rosuvastatin concentration in plasma.

    Measured: Up to Day 11

  3. PK in plasma metformin

    Metformin concentration in plasma.

    Measured: Up to Day 14

  4. PK in plasma povorcitinib

    Povorcitinib concentration in plasma.

    Measured: Up to Day 17

Secondary outcomes (5)

  1. Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after first dose of study treatment.

    Measured: Up to Day 25 (Cohorts 1, 3 and 4), Up to Day 22 (Cohort 2)

  2. Additional digoxin PK parameters in plasma

    Additional digoxin concentration in plasma.

    Measured: Up to Day 15

  3. Additional rosuvastatin PK parameters in plasma

    Additional rosuvastatin concentration in plasma.

    Measured: Up to Day 11

  4. Additional metformin PK parameters in plasma

    Additional metformin concentration in plasma.

    Measured: Up to Day 14

  5. PK in plasma povorcitinib

    Povorcitinib concentration in plasma.

    Measured: Up to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start19 Jun 2024
  3. Primary completion15 Jan 2025
  4. Study completion15 Jan 2025

Resources

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
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06416800
Sponsor's protocol ID
INCB54707-110
Status last verified
Feb 2025
First submitted
29 Apr 2024
Last updated
6 Feb 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Digoxin, Rosuvastatin and Metformin in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.

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 9 inclusion and 32 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 6 Feb 2025. 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 United States. 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. 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?

Pharmacokinetic (PK) in plasma digoxin (time frame: Up to Day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06416800.

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 6 Feb 2025.

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