Advanced MalignanciesPhase 1NCT04831996
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Renal Function and Renal Impairment.
A Phase 1 study testing parsaclisib in people with Advanced Malignancies, run by Incyte Corporation at 4 sites in United States.
Trial summary
The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal renal function and participants with renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- parsaclisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 May 2021to 8 Jul 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 18 to 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be classified at screening by renal function based on eGFR as calculated by the MDRD formula and requirement for HD (Group 5).
- Participants eligible for Group 5 with ESRD have received HD for at least 3 months prior to screening.
- Participants eligible for Group 1 should be in good health as determined by no clinically significant deviations from normal for medical history, physical examination, vital signs, 12-lead ECGs, or clinical laboratory determinations at screening or Day -1.
- Participants eligible for Groups 2 through 5 may have medical findings consistent with their degree of renal dysfunction.
- Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.
- 0Body mass index within the range 18.0 to 40.0 kg/m2 (inclusive) at screening.
- Willingness to avoid pregnancy or fathering children.
- Ability to swallow and retain oral medication.
Who cannot join
- History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening. Evidence of rapidly deteriorating renal function.
- Participants who have a current, functioning organ transplant or have a scheduled organ transplant within 6 weeks after check-in.
- History of malignancy within 5 years of screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
- History of clinically significant gastrointestinal disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.
- Participants eligible for Group 1 who have a history of renal disease or renal injury as indicated by an abnormal, clinically significant renal function profile at screening or Day -1.
- Participants eligible for Groups 2 through 5 who have had a change in disease status within 30 days of screening, as documented by the participant's medical history, deemed clinically significant by the investigator.
Show all 28Show fewer
- History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study.
- Any major surgery within 4 weeks of screening.
- Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only).
- Blood transfusion within 4 weeks of Day -1 (for Groups 1 through 4) or Period 1, Day
- 1 (Group 5).
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
- Positive test for HBV (HBsAg, HBsAg antibody, and hepatitis B core antibody), HCV (HCV antibody), or HIV. Participants whose results are compatible with prior immunization for HBV may be included at the discretion of the investigator.
- Participants eligible for Group 1 who have used tobacco- or nicotine-containing products within 6 months of screening.
- Participants eligible for Groups 2 through 5 who smoke > 10 cigarettes per day or equivalent use of other tobacco- or nicotine-containing products and are unwilling to refrain from tobacco or nicotine use on dosing days and abide by CRU restrictions.
- Positive breath test for ethanol or positive urine or serum screen for drugs of abuse that is not otherwise explained by permitted concomitant medications.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) of study drug administration 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) of study drug administration with strong or moderate inducer or inhibitor of CYP3A4, P-gp,or BCRP.
- For participants eligible for Group 1, use of prescription drugs within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days of study drug administration. However, occasional paracetamol, ibuprofen, and standard-dose vitamins are permitted.
- For participants eligible for Groups 2 through 5, use of prescription drugs within 14 days of study drug administration, with the exception of established therapy for renal disease and the treatment of associated disorders that have been stable for at least 7 days prior to study drug administration, as approved by the investigator and in consultation with the sponsor's medical monitor.
- Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, or currently receiving systemic antibiotics. Current clinically significant viral infection at screening or check-in.
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- Inability to undergo venipuncture or tolerate venous access.
- Participants eligible for Group 5 that are not expected to continue HD treatment for the duration of the study.
- Receipt of live (including attenuated) vaccines or anticipation of need for such a vaccine during the study (Note: nonlive or inactivated vaccines are allowed up to 2 weeks prior to the first dose of study drug).
- Known hypersensitivity or severe reaction to parsaclisib or excipients of parsaclisib.
- History of alcoholism within 3 months of screening.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Pharmacology of Miami
Hialeah, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
Prism Research
Saint Paul, Minnesota, 55114
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Parsaclisib in Participants With Normal Renal Function and Participants With Renal Impairment
The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal renal function and participants with renal impairment.
- Conditions
- Advanced Malignancies
- Being tested
- parsaclisib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parsaclisibDrug
Also called INCB050465
parsaclisib will be administered orally after 8 hours of fasting.
| Study group | Role | What they receive |
|---|---|---|
| Treat Group 1 : Normal Renal Function | Experimental | eGFR: ≥ 90 mL/min/1.73 m^2 Receives: Drug: parsaclisib |
| Treat Group 2 : Mild Renal Impairment | Experimental | eGFR: 60-89 mL/min/1.73 m^2 Receives: Drug: parsaclisib |
| Treat Group 3 : Moderate Renal Impairment | Experimental | eGFR: 30-59 mL/min/1.73 m^2 Receives: Drug: parsaclisib |
| Treat Group 4 : Severe Renal Impairment | Experimental | eGFR: 15-29 mL/min/1.73 m^2 and not on Hemo Dialysis Receives: Drug: parsaclisib |
| Treat Group 5 : Kidney Failure | Experimental | eGFR: < 15 mL/min/1.73 m^2 on Hemo Dialysis Receives: Drug: parsaclisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Parameter Groups1-4 : Cmax of parsaclisib
Maximum Observed Plasma Concentration of parsaclisib
Measured: 4 Days
Pharmacokinetics Parameter Groups 1-4 : AUC 0-∞ of parsaclisib
Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Measured: 4 Days
Pharmacokinetics Parameter Groups 1-4 : AUC(0-t) of parsaclisib
Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
Measured: 4 Days
Pharmacokinetics Parameter Group 5: Cmax of parsaclisib
Maximum Observed Plasma Concentration of parsaclisib
Measured: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : AUC 0-∞ of parsaclisib
Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Measured: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5: AUC(0-t) of parsaclisib
Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
Measured: 4 Days for period 1 and 2
Secondary outcomes (11)
Number of Treatment Emergent Adverse Events (TEAE) Groups 1-4
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Measured: up to 11 Days
Pharmacokinetics Parameter Groups 1-4 : tmax of parsaclisib
Time to reach maximum plasma concentration of parsaclisib
Measured: 4 Days
Pharmacokinetics Parameter Groups 1-4 : t1/2 of parsaclisib
Apparent terminal phase disposition half-life of parsaclisib
Measured: 4 Days
Pharmacokinetics Parameter Groups 1-4 : CL/F of parsaclisib
Oral dose clearance of parsaclisib
Measured: 4 Days
Pharmacokinetics Parameter Groups 1-4 : Vz/F of parsaclisib
Apparent oral dose volume of distribution of parsaclisib
Measured: 4 Days
Pharmacokinetics Parameter Group 5 : tmax of parsaclisib
Time to reach maximum plasma concentration of parsaclisib
Measured: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : t1/2 of parsaclisib
Apparent terminal phase disposition half-life of parsaclisib
Measured: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : CL/F of parsaclisib
Oral dose clearance of parsaclisib
Measured: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : Vz/F of parsaclisib
Apparent oral dose volume of distribution of parsaclisib
Measured: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 during Dialysis - : AUC1-5 of parsaclisib
Area Under the Concentration-time Curve From 1 to 5 hrs. of parsaclisib
Measured: 4 Days for period 1 and 2
Number of Treatment Emergent Adverse Events (TEAE) Group 5
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Measured: up to 18 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start4 May 2021
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831996
- Sponsor's protocol ID
- INCB 50465-109
- Status last verified
- Aug 2022
- First submitted
- 2 Apr 2021
- Last updated
- 17 Aug 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 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Parsaclisib in Participants With Normal Renal Function and Participants With Renal Impairment
- ClinicalTrials.gov ID
- NCT04831996
- Acronym / sponsor ID
- INCB 50465-109
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 May 2021 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 5 Apr 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.
The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal renal function and participants with renal impairment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treat Group 1 : Normal Renal Function | Experimental | Drug: parsaclisibeGFR: ≥ 90 mL/min/1.73 m^2 |
| Treat Group 2 : Mild Renal Impairment | Experimental | Drug: parsaclisibeGFR: 60-89 mL/min/1.73 m^2 |
| Treat Group 3 : Moderate Renal Impairment | Experimental | Drug: parsaclisibeGFR: 30-59 mL/min/1.73 m^2 |
| Treat Group 4 : Severe Renal Impairment | Experimental | Drug: parsaclisibeGFR: 15-29 mL/min/1.73 m^2 and not on Hemo Dialysis |
| Treat Group 5 : Kidney Failure | Experimental | Drug: parsaclisibeGFR: < 15 mL/min/1.73 m^2 on Hemo Dialysis |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants will be classified at screening by renal function based on eGFR as calculated by the MDRD formula and requirement for HD (Group 5).
- Participants eligible for Group 5 with ESRD have received HD for at least 3 months prior to screening.
- Participants eligible for Group 1 should be in good health as determined by no clinically significant deviations from normal for medical history, physical examination, vital signs, 12-lead ECGs, or clinical laboratory determinations at screening or Day -1.
- Participants eligible for Groups 2 through 5 may have medical findings consistent with their degree of renal dysfunction.
- Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.
Key exclusion criteria (28 listed)
- History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening. Evidence of rapidly deteriorating renal function.
- Participants who have a current, functioning organ transplant or have a scheduled organ transplant within 6 weeks after check-in.
- History of malignancy within 5 years of screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
- History of clinically significant gastrointestinal disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.
- Participants eligible for Group 1 who have a history of renal disease or renal injury as indicated by an abnormal, clinically significant renal function profile at screening or Day -1.
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 |
|---|---|---|
| parsaclisibAlso: INCB050465parsaclisib will be administered orally after 8 hours of fasting. | Drug | Treat Group 1 : Normal Renal Function, Treat Group 2 : Mild Renal Impairment, Treat Group 3 : Moderate Renal Impairment, Treat Group 4 : Severe Renal Impairment, Treat Group 5 : Kidney Failure |
Primary outcome
Pharmacokinetics Parameter Groups1-4 : Cmax of parsaclisib
Time frame: 4 Days
Maximum Observed Plasma Concentration of parsaclisib
Pharmacokinetics Parameter Groups 1-4 : AUC 0-∞ of parsaclisib
Time frame: 4 Days
Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Pharmacokinetics Parameter Groups 1-4 : AUC(0-t) of parsaclisib
Time frame: 4 Days
Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
Pharmacokinetics Parameter Group 5: Cmax of parsaclisib
Time frame: 4 Days for period 1 and 2
Maximum Observed Plasma Concentration of parsaclisib
Pharmacokinetics Parameter Group 5 : AUC 0-∞ of parsaclisib
Time frame: 4 Days for period 1 and 2
Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Pharmacokinetics Parameter Group 5: AUC(0-t) of parsaclisib
Time frame: 4 Days for period 1 and 2
Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
11 secondary outcomes
Number of Treatment Emergent Adverse Events (TEAE) Groups 1-4
Time frame: up to 11 Days
Pharmacokinetics Parameter Groups 1-4 : tmax of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Groups 1-4 : t1/2 of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Groups 1-4 : CL/F of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Groups 1-4 : Vz/F of parsaclisib
Time frame: 4 Days
Pharmacokinetics Parameter Group 5 : tmax of parsaclisib
Time frame: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : t1/2 of parsaclisib
Time frame: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : CL/F of parsaclisib
Time frame: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 : Vz/F of parsaclisib
Time frame: 4 Days for period 1 and 2
Pharmacokinetics Parameter Group 5 during Dialysis - : AUC1-5 of parsaclisib
Time frame: 4 Days for period 1 and 2
Number of Treatment Emergent Adverse Events (TEAE) Group 5
Time frame: up to 18 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 17 Aug 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing parsaclisib in people with Advanced Malignancies, run by Incyte Corporation at 4 sites 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 8 inclusion and 28 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Pharmacokinetics Parameter Groups1-4 : Cmax of parsaclisib (time frame: 4 Days). The study lists 6 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 17 Aug 2022.