Healthy SubjectsPhase 1NCT02321644

Effect of UV Exposure on the PD of Multiple Doses of CC-90001 and Pilot Food Effect Study

A Phase 1 study testing CC-90001 in people with Healthy Subjects, run by Celgene Corporation at 2 sites 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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: CC-90001
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 2 sitesUnited States
Study dates: Nov 2014to Feb 2015
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 Document (ICD) prior to any study-related assessments/procedures being performed
Must be able to communicate with the Investigator and to understand and adhere to the study visit schedule and other protocol requirements
Must be a male or female*, aged 18 years of age to 65 years of age (inclusive) at the time of signing the ICD
Women of child-bearing potential (WCBP)*must agree to ongoing pregnancy testing during the course of the study, and at the end of the study. This applies even if the subject practices true abstinence from heterosexual contact
The female subjects must either commit to true abstinence** from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, 2 highly effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for at least 28 days after discontinuation of study drug
Females not of child-bearing potential should have been either surgically sterilized at least 6 months prior to screening (hysterectomy or bilateral tubal ligation) or be postmenopausal (defined as 24 months with no menses prior to Screening, AND with a plasma follicle stimulating hormone (FSH) > 40 IU/L at screening). Documentation will be required in cases of tubal ligation

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Males must practice true abstinence** or agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a WCBP while on study drug, or while participating in this study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy
True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]
Has a body mass index (BMI = weight [kg]/(height [m2]) between 18 and 33 kg/m2 (inclusive)
Must be healthy as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECGs
Must be afebrile (febrile is defined as ≥ 38 °C or 100.3° Fahrenheit)
Systolic blood pressure must be in the range of 80 to 140 mmHg, diastolic blood pressure must be in the range of 40 to 90 mmHg, and pulse rate must be in the range of 40 to 110 bpm
QTcF value ≤ 430 msec for male subjects and ≤ 450 msec for female subjects. An ECG may be repeated up to 3 times to determine subject eligibility
Additional criteria for Part 1 only:
Must be Fitzpatrick skin type I or II
Must have a valid MED obtained within 10 days prior to dosing

Who cannot join

History (ie, within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, or other major disorders
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 vaccines, within 30 days of the first dose
Use of any non-prescribed systemic or topical medication (including herbal medicines) within 14 days of the first dose administration (with the exception of vitamin/mineral supplements)
Use of any metabolic enzyme inhibitors or inducers (ie, CYP3A inducers and inhibitors or St. John's wort) within 30 days of the first dose administration
The University of Indiana "Cytochrome P450 Drug Interaction Table" should be used to determine inhibitors and/or inducers of CYP 3A4 (http://medicine.iupui.edu/clinpharm/ddis/table/aspx)

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Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME), eg, bariatric procedure
Appendectomy and cholecystectomy are acceptable
Donated blood or plasma within 8 weeks before the first dose administration
History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before dosing, or positive drug screening test reflecting consumption of illicit drugs)
History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing, or positive alcohol screen
Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb), or have a positive result to the test for HIV antibodies at Screening
Exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer)
Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products (self reported)
Subject has a history of multiple drug allergies (ie, 2 or more)
Additional Exclusion Criteria for Subjects in Part 1 Only:
Inability to evaluate the skin in and around the test sites due to sunburn, tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or any other disfiguration
Used any creams or lotions (ie, containing sun protection factor [SPF]) in the test area (ie, buttocks) within 7 days of study start (Day 1)
Participation in any test for irritation or sensitization or any test involving UV exposures on the test area within four weeks of study start
Participation in another study requiring biopsy (on the planned test area) within the past 2 months
History of wound healing or blood-clotting abnormality
History of keloid formation or hypertrophic scarring following skin injury
History of severe reactions from exposure to sunlight
History of allergy to lidocaine or other similar local anesthetics
History of allergy to epinephrine

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Covance-Daytona Beach
Daytona Beach, Florida, 32117
TKL Research
Fair Lawn, New Jersey, 07410

Other trials in United States

About this study

Official title: A Two-Part, Phase 1 Study to Evaluate Pharmacokinetics and Pharmacodynamics of Multiple Dose CC-90001 and to Evaluate the Effects of Food and Formulation on Pharmacokinetics of Single Dose CC-90001 in Healthy Subjects

This is a two-part, phase 1 study to evaluate the pharmacokinetics and pharmacodynamics of multiple doses of CC-90001 and the effects of food and formulation on the pharmacokinetics of single dose CC-90001 in healthy subjects. Part 1 involves the exposure of subjects to the minimum amount of UV-B light that causes minimally perceptible skin reddening. This will take place before dosing (baseline) and 3 times more while on increasing doses of CC-90001. Punch biopsies of the exposed areas will be taken and assessed for c-Jun terminal kinase activity. Part 2 involves evaluation of changes in pharmacokinetics of 2 formulations of CC-90001 when administered in the fasted state and after a high-fat meal.

Read the detailed description

Part 1 is an open-label, multiple-dose, 3-period, fixed-sequence study, to evaluate the effect of CC-90001 on JNK activity following UV irradiation. On the first day prior to dosing (baseline), and on the 6th day of each dosing period (Days 6, 12, and 18), twice the MED intensity of UV light will be administered to delineated sites on the subjects' buttocks. The irradiation at baseline (Day -1) should be administered at approximately the same time that irradiation is scheduled on Days 6, 12, and 18, which is at 2 hours post dose. Eight hours after UV irradiation, a skin punch biopsy will be taken from the UV exposure site. The end of confinement will be Day 19. The follow-up visit will occur 7-10 days (ie, Day 25 to Day 28) following the last dose in Period 3. An early termination (ET) visit will occur within 10 days of the day of discontinuation. The MED will be determined within 10 days of dosing in Period 1. All subjects will receive the following doses of CC-90001 in the fixed sequence below: Treatment A: 60 mg CC-90001 as AIC, QD x 6 days; Treatment B: 160 mg CC-90001 as AIC, QD x 6 days; and Treatment C: 400 mg of CC-90001 as AIC, QD x 6 days. Subjects will be confined at the unit from Day -1 until discharge on Day 19 after all safety assessments.

In Part 2 subjects will be assigned randomly to one of three dosing sequences during which they will receive one of the following dosing regimens:

Treatment D: 2 x 100 mg CC-90001 as AIC, single oral dose administered under fasted conditions.
Treatment E: 1 x 200 mg CC-90001 [formulated tablet(s)] single oral dose administered under fasted conditions
Treatment F: 1 x 200 mg CC-90001 [formulated tablet(s)] single oral dose administered under fed conditions (standard high fat breakfast).

Conditions: Healthy Subjects
Being tested: CC-90001
Keywords: CC-90001, PHARMACOKINETICS, PHARMACODYNAMICS, HEALTHY SUBJECTS, SINGLE DOSE, MULTIPLE DOSE, PUNCH BIOPSY

What participants receive

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

CC-90001Drug
CC-90001 Active-ingredient-in-capsule and formulated tablet

Study groups in NCT02321644
Study group	Role	What they receive
CC-90001	Experimental	Part 1: All subjects will receive the following doses of CC-90001 in the fixed sequence below: Treatment A: 60 mg CC-90001 as Active-Ingredient-in-Capsule, once daily x 6 days Treatment B: 160 mg CC-90001 as Active-Ingredient-in-Capsule, once daily x 6 days Treatment C: 400 mg of CC-90001 as Active-Ingredient-in-Capsule, once daily x 6 days Receives: Drug: CC-90001
CC-90001 2 X 100mg fasted	Experimental	Treatment D: 2 x 100 mg CC-90001 as Active-Ingredient-in-Capsule, single oral dose administered under fasted conditions. Receives: Drug: CC-90001
CC-90001 1 X 200mg fasted	Experimental	Treatment E: 1 x 200 mg CC-90001 [formulated tablet(s)] single oral dose administered under fasted conditions Receives: Drug: CC-90001
CC-90001 1 X 200mg fed	Experimental	Treatment F: 1 x 200 mg CC-90001 [formulated tablet(s)] single oral dose administered under fed conditions (standard high fat breakfast). Receives: Drug: CC-90001

What is being measured

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

Pharmacokinetics- Cmax
Maximum observed plasma concentration
Measured: Days 1, 2, 3, and 4
Pharmacokinetics- Tmax
Time to Cmax
Measured: Days 1, 2, 3, and 4
Pharmacokinetics- AUC∞
Area under the plasma concentration time curve from time zero extrapolated to infinity
Measured: Days 1, 2, 3, and 4
Pharmacokinetics- AUCt
Area under the plasma concentration time curve from time zero to the last quantifiable concentration
Measured: Days 1, 2, 3, and 4
Pharmacokinetics- AUCτ
Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
Measured: Days 1, 2, 3, and 4
Pharmacokinetics- t1/2
Terminal phase elimination half-life
Measured: Days 1, 2, 3, and 4
Pharmacokinetics- CL/F
Apparent total plasma clearance when dosed orally
Measured: Days 1, 2, 3, and 4
Pharmacokinetics- Vz/F
Apparent total volume of distribution when dosed orally, based on the terminal phase
Measured: Days 1, 2, 3, and 4
Pharmacodynamics: Phospho-c-Jun IHC data will be subjectively scored on a scale of 0 to 4 based on the intensity and number of epidermal keratinocyte nuclei stained within the tissue section by trained individuals blinded to treatment
For Part 1 only the Phospho-c-Jun IHC data will be subjectively scored on a scale of 0 to 4 based on the intensity and number of epidermal keratinocyte nuclei stained within the tissue section by trained individuals blinded to treatment.
Measured: Approximately 6 days

Secondary outcomes (1)

Adverse Event (AE)
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. AE will be monitored, evaluated, recorded and reported by using following:
- Physical examinations (PEs)
- Vital sign measurements
- 12 lead electrocardiograms (ECGs)
- Clinical laboratory safety tests
- Concomitant medications and procedures
Measured: approximately 10 weeks

Timeline

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

Nov 2014Feb 2015

First posted22 Dec 2014 (estimated)
Study startNov 2014
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies 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: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02321644
Sponsor's protocol ID: CC-90001-CP-002
Status last verified: Aug 2015
First submitted: 17 Dec 2014
Last updated: 19 Aug 2015
Results posted: No
Data monitoring committee: No

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

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-Part, Phase 1 Study to Evaluate Pharmacokinetics and Pharmacodynamics of Multiple Dose CC-90001 and to Evaluate the Effects of Food and Formulation on Pharmacokinetics of Single Dose CC-90001 in Healthy Subjects
ClinicalTrials.gov ID: NCT02321644
Acronym / sponsor ID: CC-90001-CP-002
Conditions: Healthy Subjects
Keywords: CC-90001, PHARMACOKINETICS, PHARMACODYNAMICS, HEALTHY SUBJECTS, SINGLE DOSE, MULTIPLE DOSE, PUNCH BIOPSY
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Celgene CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 22 Dec 2014 (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.

Detailed description

In Part 2 subjects will be assigned randomly to one of three dosing sequences during which they will receive one of the following dosing regimens:

Treatment D: 2 x 100 mg CC-90001 as AIC, single oral dose administered under fasted conditions.
Treatment E: 1 x 200 mg CC-90001 [formulated tablet(s)] single oral dose administered under fasted conditions
Treatment F: 1 x 200 mg CC-90001 [formulated tablet(s)] single oral dose administered under fed conditions (standard high fat breakfast).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
CC-90001	Experimental	Drug: CC-90001Part 1: All subjects will receive the following doses of CC-90001 in the fixed sequence below: Treatment A: 60 mg CC-90001 as Active-Ingredient-in-Capsule, once daily x 6 days Treatment B: 160 mg CC-90001 as Active-Ingredient-in-Capsule, once daily x 6 days Treatment C: 400 mg of CC-90001 as Active-Ingredient-in-Capsule, once daily x 6 days
CC-90001 2 X 100mg fasted	Experimental	Drug: CC-90001Treatment D: 2 x 100 mg CC-90001 as Active-Ingredient-in-Capsule, single oral dose administered under fasted conditions.
CC-90001 1 X 200mg fasted	Experimental	Drug: CC-90001Treatment E: 1 x 200 mg CC-90001 [formulated tablet(s)] single oral dose administered under fasted conditions
CC-90001 1 X 200mg fed	Experimental	Drug: CC-90001Treatment F: 1 x 200 mg CC-90001 [formulated tablet(s)] single oral dose administered under fed conditions (standard high fat breakfast).

Who may qualify

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

Key inclusion criteria (16 listed)

Must understand and voluntarily sign a written Informed Consent Document (ICD) prior to any study-related assessments/procedures being performed
Must be able to communicate with the Investigator and to understand and adhere to the study visit schedule and other protocol requirements
Must be a male or female*, aged 18 years of age to 65 years of age (inclusive) at the time of signing the ICD
Males must practice true abstinence** or agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a WCBP while on study drug, or while participating in this study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy
True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]

Key exclusion criteria (25 listed)

History (ie, within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, or other major disorders
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 vaccines, within 30 days of the first dose
Use of any non-prescribed systemic or topical medication (including herbal medicines) within 14 days of the first dose administration (with the exception of vitamin/mineral supplements)
Use of any metabolic enzyme inhibitors or inducers (ie, CYP3A inducers and inhibitors or St. John's wort) within 30 days of the first dose administration

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-90001CC-90001 Active-ingredient-in-capsule and formulated tablet	Drug	CC-90001, CC-90001 1 X 200mg fasted, CC-90001 1 X 200mg fed, CC-90001 2 X 100mg fasted

Primary outcome

Pharmacokinetics- Cmax
Time frame: Days 1, 2, 3, and 4
Maximum observed plasma concentration
Pharmacokinetics- Tmax
Time frame: Days 1, 2, 3, and 4
Time to Cmax
Pharmacokinetics- AUC∞
Time frame: Days 1, 2, 3, and 4
Area under the plasma concentration time curve from time zero extrapolated to infinity
Pharmacokinetics- AUCt
Time frame: Days 1, 2, 3, and 4
Area under the plasma concentration time curve from time zero to the last quantifiable concentration
Pharmacokinetics- AUCτ
Time frame: Days 1, 2, 3, and 4
Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
Pharmacokinetics- t1/2
Time frame: Days 1, 2, 3, and 4
Terminal phase elimination half-life
Pharmacokinetics- CL/F
Time frame: Days 1, 2, 3, and 4
Apparent total plasma clearance when dosed orally
Pharmacokinetics- Vz/F
Time frame: Days 1, 2, 3, and 4
Apparent total volume of distribution when dosed orally, based on the terminal phase
Pharmacodynamics: Phospho-c-Jun IHC data will be subjectively scored on a scale of 0 to 4 based on the intensity and number of epidermal keratinocyte nuclei stained within the tissue section by trained individuals blinded to treatment
Time frame: Approximately 6 days
For Part 1 only the Phospho-c-Jun IHC data will be subjectively scored on a scale of 0 to 4 based on the intensity and number of epidermal keratinocyte nuclei stained within the tissue section by trained individuals blinded to treatment.

1 secondary outcome

Adverse Event (AE)
Time frame: approximately 10 weeks

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 19 Aug 2015.

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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.

Daniel Weiss, MD study director

Celgene Corporation

2 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 CC-90001 in people with Healthy Subjects, run by Celgene Corporation at 2 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 16 inclusion and 25 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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- Cmax (time frame: Days 1, 2, 3, and 4). The study lists 9 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 NCT02321644.

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 19 Aug 2015.