Healthy VolunteersPhase 1NCT02433457

Relative Bioavailability Study of CC-292

A Phase 1 study testing CC-292 and Oral Omeprazole (OMP) in people with Healthy Volunteers, run by Celgene 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

Search all trials

Trial summary

To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292 P22 tablet. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: CC-292 and Oral Omeprazole (OMP)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 26 May 2014to 26 Sep 2014
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Must understand and voluntarily sign a written Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
Must be able to communicate with the Investigator, understand, and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
Must be a male or female subject from any race between 18 to 65 years of age (inclusive) at the time of signing the ICF, and in good health as determined by Physical Examinations (PE).
Must comply with the following acceptable forms of contraception:
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception with male condoms NOT made out of natural animal membrane (e.g., latex or polyurethane condoms are acceptable) while on study drug, and for at least 90 days after the last dose of study drug.
Females of childbearing potential (FCBP) 1 must have a negative pregnancy test at Screening and at Baseline (i.e., on Day -1). FCBP who engage in activity in which conception is possible must agree to use one of the following forms of contraception during their entire participation in the study and for at least 30 days after administration of the last dose of study drug:

Show all 14Show fewer

Option 1: Any one of the following: non-oral hormonal contraception (e.g., injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation; or a partner with a vasectomy; OR
Option 2: Oral contraceptive pills PLUS one additional barrier method of the following: (a) male or female condom NOT made out of natural animal membrane (e.g., latex or polyurethane is acceptable); (b) diaphragm with spermicide; (c) cervical cap with spermicide; or (d) contraceptive sponge with spermicide; OR
Option 3: TWO of the following barrier methods: (a) male or female condom NOT made out of natural animal membrane (e.g., latex or polyurethane is acceptable); (b) diaphragm with spermicide; (c) cervical cap with spermicide; or (d) a contraceptive sponge with spermicide.
Note: All other females must have been surgically sterilized for at least 6 months before Screening (proper documentation required), or be postmenopausal (defined as 24 months without menses before Screening, and an estradiol level of < 30 pg/mL and a plasma Follicle Stimulating Hormone (FSH) level > 40 IU/L at Screening).
Must have a Body Mass Index (BMI) between 18 and 33 kg/m2 (inclusive).
No clinically significant laboratory test results, as determined by the Investigator.
Must be afebrile, with supine systolic BP of 90 to 140 mmHg, a supine diastolic Blood Pressure (BP) of 60 to 90 mmHg, and pulse rate of 40 to 110 bpm.
Must have a normal or clinically acceptable 12-lead Electrocardiogram (ECG) at Screening. Male subjects must have a QTcF value ≤ 430 msec. Female subjects must have a QTcF value ≤ 450 msec.

Who cannot join

Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study.
Use of any prescribed systemic or topical medication (including but not limited to antibiotics, analgesics, anesthetics, etc.) prior to 30 days of the first dose administration, unless Sponsor agreement is obtained.
Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 7 days of the first dose administration, unless Sponsor agreement is obtained.
Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism and excretion (e.g., bariatric procedure), or plans to have elective or medical procedures during the conduct of the trial. Subjects post cholecystectomy and post appendectomy may be included.
Exposure to an investigational drug within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).

Show all 13Show fewer

Donated blood or plasma prior to 4 weeks before the first dose administration to a blood bank or blood donation center.
History of multiple drug allergies (i.e., two or more);
History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) prior to 2 years before first dose administration, or a positive drug screen reflecting consumption of illicit drugs.
History of alcohol abuse (as defined by the current version of the DSM) prior to 2 years before dosing, or a positive alcohol screen.
Known to have hepatitis, or known to be a carrier of the Hepatitis B Surface Antigen (HBsAg), or Hepatitis C Virus Antibody (HCVAb), or have a positive result to the test for HBsAg, HCVAb, or Human Immunodeficiency Virus (HIV) antibodies at Screening.
History of smoking or the use of nicotine containing products prior to 3 months of Screening by self reporting.
Female subjects lactating or breastfeeding a child.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research unit
Evansville, Indiana, 47710

Other trials in United States

About this study

Official title: An Open-label, Phase 1, Randomized, Seven-treatment, Seven-period, Crossover Study to Assess the Relative Bioavailability, pH Effect, Food Effect and Dose Proportionality of CC-292 Spray Dried Dispersion Formulation in Healthy Volunteers

To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292 P22 tablet.

Read the detailed description

This is a single center, open-label, randomized, seven-treatment, seven-period, crossover design. The study will consist of a screening phase, a treatment phase, and a follow-up phone call. Approximately 24 healthy adult subjects (male or female) will be enrolled.

Conditions: Healthy Volunteers
Being tested: CC-292, Oral Omeprazole (OMP)
Keywords: Healthy Volunteers, CC-292, Open-Label, Bioavailability Pharmacokinetics, Phase I

What participants receive

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

CC-292Drug
Oral Omeprazole (OMP)Drug

Study groups in NCT02433457
Study group	Role	What they receive
CC-292 SDD (Spray Dried Dispersion)300mg - Fasted Condition	Experimental	Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets) Receives: Drug: CC-292
CC-292 SDD 300mg - Fed Condition	Experimental	Single oral dose of 300 mg CC-292 SDD under fed conditions (100 mg SDD x 3 tablets) Receives: Drug: CC-292
375mg P22 - Fasted condition	Experimental	Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3) Receives: Drug: CC-292
375mg P22 Fed Condition	Experimental	Single oral dose of 375 mg P22 under fed conditions (125 mg P22 x 3) Receives: Drug: CC-292
CC-292 SDD 100 mg Fasted Condition	Experimental	Single oral dose of 100 mg CC-292 SDD under fasted conditions Receives: Drug: CC-292
SDD plus OMP (Oral Omeprazole)	Experimental	Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets) in the presence of 40 mg Receives: Drug: CC-292; Drug: Oral Omeprazole (OMP)
P22 plus OMP	Experimental	Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3) in the presence of 40 mg oral OMP Receives: Drug: CC-292; Drug: Oral Omeprazole (OMP)

What is being measured

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

Pharmacokinetics - Cmax
Maximum observed concentration in plasma
Measured: 48 hours
Pharmacokinetics - AUC 0-t
Area under the plasma concentration-time curve from time zero to the last measured time point
Measured: 48 hours
Pharmacokinetics - AUC 0-24
Area under the plasma concentration-time curve to 24 hours post dose
Measured: 48 hours
Pharmacokinetics - AUC 0-∞
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Measured: 48 hours
Pharmacokinetics - %AUCextrap
Percent Area under the plasma concentration-time curve extrapolated
Measured: 48 hours
Pharmacokinetics - Frel
Relative bioavailability of the CC-292 SDD formulation compared to the reference P22 formulation
Measured: 48 hours
Pharmacokinetics - Tmax
Time to Cmax
Measured: 48 hours
Pharmacokinetics - λz
Terminal disposition rate constant
Measured: 48 hours
Pharmacokinetics - t1/2
Terminal half-life
Measured: 48 hours
Pharmacokinetics - CL/F
Apparent clearance
Measured: 48 hours
Pharmacokinetics - Vz/F
Apparent volume of distribution
Measured: 48 hours

Secondary outcomes (1)

Adverse Events (AEs)
Number of subjects with adverse events
Measured: Approximatly 52 days

Timeline

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

26 May 201426 Sep 2014

First posted5 May 2015 (estimated)
Study start26 May 2014
Primary completion26 Sep 2014
Study completion26 Sep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by CelgeneThe 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02433457
Sponsor's protocol ID: CC-292-CP-002
Status last verified: Aug 2020
First submitted: 26 Mar 2015
Last updated: 13 Aug 2020
Results posted: No
Data monitoring committee: No

Publications

Cheng Y, Liu L, Xue Y, Zhou S, Li Y. An Open Label, Phase 1, Randomized, Seven-treatment, Seven-period, Crossover Study to Assess the Relative Bioavailability, pH Effect, Food Effect, and Dose Proportionality of CC-292, a Potent and Orally Available Bruton's Tyrosine Kinase Inhibitor. Eur J Drug Metab Pharmacokinet. 2022 Jul;47(4):579-592. doi: 10.1007/s13318-022-00776-7. Epub 2022 Jun 3.
PubMed 35657581

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Enrolling by invitation
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
Healthy

All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Phase 1, Randomized, Seven-treatment, Seven-period, Crossover Study to Assess the Relative Bioavailability, pH Effect, Food Effect and Dose Proportionality of CC-292 Spray Dried Dispersion Formulation in Healthy Volunteers
ClinicalTrials.gov ID: NCT02433457
Acronym / sponsor ID: CC-292-CP-002
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers, CC-292, Open-Label, Bioavailability Pharmacokinetics, Phase I
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: CelgeneIndustry (pharma, biotech, devices)
Study start: 26 May 2014 (actual)
Primary completion: 26 Sep 2014 (actual)
Study completion: 26 Sep 2014 (actual)
First posted: 5 May 2015 (estimated)
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.

To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292 P22 tablet.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
CC-292 SDD (Spray Dried Dispersion)300mg - Fasted Condition	Experimental	Drug: CC-292Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets)
CC-292 SDD 300mg - Fed Condition	Experimental	Drug: CC-292Single oral dose of 300 mg CC-292 SDD under fed conditions (100 mg SDD x 3 tablets)
375mg P22 - Fasted condition	Experimental	Drug: CC-292Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3)
375mg P22 Fed Condition	Experimental	Drug: CC-292Single oral dose of 375 mg P22 under fed conditions (125 mg P22 x 3)
CC-292 SDD 100 mg Fasted Condition	Experimental	Drug: CC-292Single oral dose of 100 mg CC-292 SDD under fasted conditions
SDD plus OMP (Oral Omeprazole)	Experimental	Drug: CC-292, Drug: Oral Omeprazole (OMP)Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets) in the presence of 40 mg
P22 plus OMP	Experimental	Drug: CC-292, Drug: Oral Omeprazole (OMP)Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3) in the presence of 40 mg oral OMP

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Must understand and voluntarily sign a written Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
Must be able to communicate with the Investigator, understand, and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
Must be a male or female subject from any race between 18 to 65 years of age (inclusive) at the time of signing the ICF, and in good health as determined by Physical Examinations (PE).
Must comply with the following acceptable forms of contraception:
Note: All other females must have been surgically sterilized for at least 6 months before Screening (proper documentation required), or be postmenopausal (defined as 24 months without menses before Screening, and an estradiol level of < 30 pg/mL and a plasma Follicle Stimulating Hormone (FSH) level > 40 IU/L at Screening).

Key exclusion criteria (13 listed)

Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study.
Use of any prescribed systemic or topical medication (including but not limited to antibiotics, analgesics, anesthetics, etc.) prior to 30 days of the first dose administration, unless Sponsor agreement is obtained.
Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 7 days of the first dose administration, unless Sponsor agreement is obtained.
Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism and excretion (e.g., bariatric procedure), or plans to have elective or medical procedures during the conduct of the trial. Subjects post cholecystectomy and post appendectomy may be included.

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
CC-292	Drug	375mg P22 - Fasted condition, 375mg P22 Fed Condition, CC-292 SDD (Spray Dried Dispersion)300mg - Fasted Condition, CC-292 SDD 100 mg Fasted Condition, CC-292 SDD 300mg - Fed Condition, P22 plus OMP, SDD plus OMP (Oral Omeprazole)
Oral Omeprazole (OMP)	Drug	P22 plus OMP, SDD plus OMP (Oral Omeprazole)

Primary outcome

Pharmacokinetics - Cmax
Time frame: 48 hours
Maximum observed concentration in plasma
Pharmacokinetics - AUC 0-t
Time frame: 48 hours
Area under the plasma concentration-time curve from time zero to the last measured time point
Pharmacokinetics - AUC 0-24
Time frame: 48 hours
Area under the plasma concentration-time curve to 24 hours post dose
Pharmacokinetics - AUC 0-∞
Time frame: 48 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Pharmacokinetics - %AUCextrap
Time frame: 48 hours
Percent Area under the plasma concentration-time curve extrapolated
Pharmacokinetics - Frel
Time frame: 48 hours
Relative bioavailability of the CC-292 SDD formulation compared to the reference P22 formulation
Pharmacokinetics - Tmax
Time frame: 48 hours
Time to Cmax
Pharmacokinetics - λz
Time frame: 48 hours
Terminal disposition rate constant
Pharmacokinetics - t1/2
Time frame: 48 hours
Terminal half-life
Pharmacokinetics - CL/F
Time frame: 48 hours
Apparent clearance
Pharmacokinetics - Vz/F
Time frame: 48 hours
Apparent volume of distribution

1 secondary outcome

Adverse Events (AEs)
Time frame: Approximatly 52 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 13 Aug 2020.
Derived from this study: PubMed 35657581Cheng Y, Liu L, Xue Y, Zhou S, Li Y. An Open Label, Phase 1, Randomized, Seven-treatment, Seven-period, Crossover Study to Assess the Relative Bioavailability, pH Effect, Food Effect, and Dose Proportionality of CC-292, a Potent and Orally Available Bruton's Tyrosine Kinase Inhibitor. Eur J Drug Metab Pharmacokinet. 2022 Jul;47(4):579-592. doi: 10.1007/s13318-022-00776-7. Epub 2022 Jun 3.

Related trials for Healthy Volunteers

Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Enrolling by invitation
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
Healthy

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.

Daniel Weiss, MD study director

Celgene Corporation

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 CC-292 and Oral Omeprazole (OMP) in people with Healthy Volunteers, run by Celgene 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 14 inclusion and 13 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 13 Aug 2020. 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?

Pharmacokinetics - Cmax (time frame: 48 hours). The study lists 11 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 NCT02433457, which also lists 1 linked publication.

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 13 Aug 2020.