Atopic DermatitisPhase 1/2NCT00697710
A Phase Ib/IIa, Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of S-777469 in Subjects With Atopic Dermatitis
A Phase 1/2 study testing 50 mg S-777469, 200 mg S-777469 and 800 mg S-777469 in people with Atopic Dermatitis, run by Shionogi at 1 site in United States.
Trial summary
The purpose of this randomized, double-blind, placebo-controlled, sequential-cohort, dose-escalation study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-777469, a CB2 cannabinoid receptor agonist, in subjects with mild to moderate atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- 50 mg S-777469, 200 mg S-777469 and 800 mg S-777469
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Sep 2008
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Otherwise healthy males and females between 18 and 65 years of age at the time of obtaining the written informed consent
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent
- Subject satisfies the diagnostic criteria for mild to moderate atopic dermatitis (AD) as judged by the Physician's Global Assessment Score and modified criteria
- All of these features must be present:
- Pruritus
- Eczema (acute, subacute, chronic) with the following characteristics:current or prior flexural lesions, lesions on the face, neck, and extensor surfaces, sparing of groin and axillary regions (no lesions)
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- History of a chronic and relapsing course of eczema
- Personal or family history of atopy
- Subject is judged to be in general good health based on medical history, physical examination, and routine laboratory tests performed at screen and baseline, with the exception of diagnosis of mild to moderate AD
- Subject has a negative laboratory results for hepatitis B surface antigen, hepatitis C virus (anti-HCV antibodies), and Human Immunodeficiency Virus antibody screens
- Female subjects have a negative pregnancy test at screen and baseline
- Serum creatinine in the normal range [0.5 to 1.5 mg/dl]
- Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and gamma glutamyl transpeptidase [GGT]) within normal range
- Negative screen for drugs of abuse at screen and baseline
- Subject agrees to refrain from smoking for the duration of the trial
- Subject has no clinically significant abnormality on screening or baseline electrocardiogram (ECG). Inclusion of a subject with any ECG abnormality at screening or baseline must be jointly agreed upon by both Study Investigator and Sponsor to be not clinically relevant within the context of the study, prior to enrollment
- Use of adequate birth control, if of reproductive potential and sexually active Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional month after last administration/dose of study drug.
- For females, adequate birth control methods will be defined as: oral contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam For males adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam
- For female subjects, menopause is defined as one year without menses; if in question, a follicle-stimulating hormone of >40 U/ml must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable
- Subject has not used any topical or systemic treatments for AD for 3 weeks prior to the Day 1 visit (i.e., the washout period), including topical corticosteroids (3 weeks prior to the Day 1 visit), antihistamines (3 weeks prior to the Day 1 visit), herbal preparation, cosmetic or emollient preparations (3 weeks prior to the Day 1 visit), immunosuppressant drugs or corticosteroids (3 weeks prior to the Day 1 visit), any other AD treatments (including light treatment) for 3 weeks prior to the Day 1 visit
- Subject is willing to completely avoid the use of any prescription or nonprescription (including over the counter) drugs or any topical preparations [other than those topical emollient preparations provided by the study site during screening, e.g., Cetaphil® cream] for 3 weeks prior to the first dose of study drug and during the entire study
- If a subject does not discontinue all prior medications within 3 weeks of study start, he/she may be included in the study only if both the Study Investigator and Sponsor's Medical Monitor agree that this is not clinically relevant within the context of the study
- Use of hormone replacement therapy (for postmenopausal females) and/or use of oral, implantable, transdermal, or injectable contraceptive(s) will be allowed
- Subject is willing to avoid strenuous physical activity (i.e., strenuous or unaccustomed weight lifting, running, exercise, etc.) from the screening visit, throughout the study, and until the post-study follow-up visit
- Subject is willing to avoid grapefruit-containing products/medications for 72 hours prior to entry into the clinical research unit and for the duration of the study
- Subject has no history of frequent or recent acetaminophen use and is willing to refrain from use of acetaminophen throughout the trial and for 4 days after the last dose
Who cannot join
- Subjects will not be eligible if they meet any of the following criteria:
- Subject is under the age of legal consent (see inclusion criteria), is mentally or legally incapacitated, has significant emotional problems at the time of study entry, or has a history of psychiatric disorders
- Active dermatologic conditions which may confound the diagnosis of AD, such as scabies, allergic contact dermatitis, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, or psoriasis
- History of malignancy not in remission for >5 years
- Presence of comorbid conditions that would preclude participation in the study, including:
- Immune compromised state, including recent chemotherapy, immunotherapy, or organ transplant History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological History or clinical manifestations of significant neurological or psychiatric disorders Subject has an active, intercurrent infection Subject has a history of clinically significant hypersensitivity, anaphylaxis, or allergies to any drug compound In no circumstances should a subject who did not qualify under inclusion criteria regarding liver function tests (ALT, AST, and GGT) be re-screened and/or re-qualified for this study
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- Subject has any acute or chronic condition or prior therapy that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study or otherwise would make the subject unsuitable for this study
- Subject has a history of drug abuse within 1 year prior to Day 1
- Subject consumes excess amounts of alcohol, defined as exceeding an average of 14 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor, or any combination of them) within 2 months prior to Study Entry, or is unwilling to comply with the restricted use of alcohol from screening, throughout the study, and until study completion (post-study visit)
- Subject has used any systemic antibiotics for 3 weeks prior to the Day 1 visit (washout period)
- Subject is pregnant or lactating or intends to become pregnant or, in the case of a male subject, intends to father a child during the study period and for 1 month after the last dose of study medication
- Subject requires use of immunosuppressive drugs such as oral corticosteroids or inhaled corticosteroids
- Subject has donated blood within 6 weeks prior to Day 1 or plasma within 2 weeks prior to screening, or received blood products within 2 months prior to Day 1
- Subject has poor peripheral venous access
- Subject has participated in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Day 1
- Any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate to, or complete, the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib/IIa, Multiple-Dose, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of S-777469 in Subjects With Mild to Moderate Atopic Dermatitis
The purpose of this randomized, double-blind, placebo-controlled, sequential-cohort, dose-escalation study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-777469, a CB2 cannabinoid receptor agonist, in subjects with mild to moderate atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- 50 mg S-777469, 200 mg S-777469, 800 mg S-777469, Placebo
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg S-777469Drug
S-777469, 50 mg BID
200 mg S-777469Drug
S-777469, 200 mg BID
800 mg S-777469Drug
S-777469, 800 mg BID
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | 50 mg S-777469 or Placebo, BID Receives: Drug: 50 mg S-777469; Drug: Placebo |
| Cohort B | Experimental | 200 mg S-777469 or Placebo, BID Receives: Drug: 200 mg S-777469; Drug: Placebo |
| Cohort C | Experimental | 800 mg S-777469 or Placebo, BID Receives: Drug: 800 mg S-777469; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessments
Safety assessments included adverse event monitoring, vital sign measurements, physical examination measurements, 12-lead electrocardiograms assessments, and standard clinical laboratory safety tests (hematology, blood chemistry, and urinalysis).
Measured: Throughout the study period
Pharmacokinetic Assessments
Pharmacokinetic endpoints included Cmax, Tmax, T1/2,12hr, T1/2,z, and AUC0-12h for each dose level of S-777469 based on the sampling schedule. Time to achieve steady state was determined for each dose level. Serum protein binding of S-777469 was determined for all cohorts. Plasma and urine concentrations of S-777469 was determined for single dose and multiple doses for all cohorts. The plasma and urine samples were used for determination of concentrations of metabolites of S-777469. Plasma and urine samples for single dose and multiple doses for Cohort B was used for metabolite profiling.
Measured: Days 1, 7, and 14
Secondary outcomes (1)
Efficacy assessment: To assess the potential anti-pruritic and anti-inflammatory efficacy of S-777469 after single-dose administration and twice daily administration in subjects with mild-to-moderate Atopic Dermatitis
The efficacy endpoints included Physician's Global Assessment, Patient Assessment of Pruritus (Visual Analog Scale), Subject Diary Cards, Itching Score, Severity Scoring Of Atopic Dermatitis Index for assessment of Eczema, Thymus And Activation-Regulated Chemokine Assessment, Digital Photography of AD lesions.
Measured: Change from baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startJul 2007
- Primary completionFeb 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by ShionogiThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697710
- Sponsor's protocol ID
- 0710D1416
- Status last verified
- Apr 2018
- First submitted
- 11 Jun 2008
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/IIa, Multiple-Dose, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of S-777469 in Subjects With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00697710
- Acronym / sponsor ID
- 0710D1416
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 16 Jun 2008 (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.
The purpose of this randomized, double-blind, placebo-controlled, sequential-cohort, dose-escalation study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-777469, a CB2 cannabinoid receptor agonist, in subjects with mild to moderate atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: 50 mg S-777469, Drug: Placebo50 mg S-777469 or Placebo, BID |
| Cohort B | Experimental | Drug: 200 mg S-777469, Drug: Placebo200 mg S-777469 or Placebo, BID |
| Cohort C | Experimental | Drug: 800 mg S-777469, Drug: Placebo800 mg S-777469 or Placebo, BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Otherwise healthy males and females between 18 and 65 years of age at the time of obtaining the written informed consent
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent
- Subject satisfies the diagnostic criteria for mild to moderate atopic dermatitis (AD) as judged by the Physician's Global Assessment Score and modified criteria
- Pruritus
- Eczema (acute, subacute, chronic) with the following characteristics:current or prior flexural lesions, lesions on the face, neck, and extensor surfaces, sparing of groin and axillary regions (no lesions)
Key exclusion criteria (16 listed)
- Subject is under the age of legal consent (see inclusion criteria), is mentally or legally incapacitated, has significant emotional problems at the time of study entry, or has a history of psychiatric disorders
- Active dermatologic conditions which may confound the diagnosis of AD, such as scabies, allergic contact dermatitis, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, or psoriasis
- History of malignancy not in remission for >5 years
- Presence of comorbid conditions that would preclude participation in the study, including:
- Immune compromised state, including recent chemotherapy, immunotherapy, or organ transplant History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological History or clinical manifestations of significant neurological or psychiatric disorders Subject has an active, intercurrent infection Subject has a history of clinically significant hypersensitivity, anaphylaxis, or allergies to any drug compound In no circumstances should a subject who did not qualify under inclusion criteria regarding liver function tests (ALT, AST, and GGT) be re-screened and/or re-qualified for this study
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 |
|---|---|---|
| 50 mg S-777469S-777469, 50 mg BID | Drug | Cohort A |
| 200 mg S-777469S-777469, 200 mg BID | Drug | Cohort B |
| 800 mg S-777469S-777469, 800 mg BID | Drug | Cohort C |
| PlaceboMatching Placebo | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
Safety Assessments
Time frame: Throughout the study period
Safety assessments included adverse event monitoring, vital sign measurements, physical examination measurements, 12-lead electrocardiograms assessments, and standard clinical laboratory safety tests (hematology, blood chemistry, and urinalysis).
Pharmacokinetic Assessments
Time frame: Days 1, 7, and 14
Pharmacokinetic endpoints included Cmax, Tmax, T1/2,12hr, T1/2,z, and AUC0-12h for each dose level of S-777469 based on the sampling schedule. Time to achieve steady state was determined for each dose level. Serum protein binding of S-777469 was determined for all cohorts. Plasma and urine concentrations of S-777469 was determined for single dose and multiple doses for all cohorts. The plasma and urine samples were used for determination of concentrations of metabolites of S-777469. Plasma and urine samples for single dose and multiple doses for Cohort B was used for metabolite profiling.
1 secondary outcome
Efficacy assessment: To assess the potential anti-pruritic and anti-inflammatory efficacy of S-777469 after single-dose administration and twice daily administration in subjects with mild-to-moderate Atopic Dermatitis
Time frame: Change from baseline to Day 14
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 1 May 2018.
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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.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 50 mg S-777469, 200 mg S-777469 and 800 mg S-777469 in people with Atopic Dermatitis, run by Shionogi 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 26 inclusion and 16 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 1 May 2018. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety Assessments (time frame: Throughout the study period). The study lists 2 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 1 May 2018.