Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-28 @ 9:51 AM
Study NCT ID:
NCT01396135
Status:
WITHDRAWN
Last Update Posted:
2018-10-30
First Post:
2011-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2011-10-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-27', 'studyFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2011-07-14', 'lastUpdatePostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 1 mg CP-601,927', 'timeFrame': '0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose'}, {'measure': 'Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 2 mg CP-601,927', 'timeFrame': '0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose'}, {'measure': 'Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 3 mg CP-601,927', 'timeFrame': '0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose'}, {'measure': 'Ctrough, Cmax, AUC0-12, Tmax and as data permit t1/2, CL/F and Rac (accumulation ratio) based on Cmax and AUC0-12 after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days', 'timeFrame': 'Day1-7'}, {'measure': 'Suicidality assessment after single dose of 1 mg CP-601,927', 'timeFrame': 'Day 0, 0 and 2 hours post-dose'}, {'measure': 'Suicidality assessment after single dose of 2 mg CP-601,927', 'timeFrame': 'Day 0, 0 and 2 hours post-dose'}, {'measure': 'Suicidality assessment after single dose of 3 mg CP-601,927', 'timeFrame': 'Day 0, 0 and 2 hours post-dose'}, {'measure': 'Suicidality assessment after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days', 'timeFrame': 'Day1-7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1', 'Pharmacokinetics', 'Healthy', 'Japanese', 'Non-smokers', 'Major Depressive Disorder', 'CP-601', '927'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3331019&StudyName=A%20Phase%201%20Study%20To%20Investigate%20The%20Pharmacokinetics%2C%20Safety%20And%20Tolerability%20Of%20CP-601%2C927%20In%20Healthy%20Japanese%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be evaluated in Japanese, healthy, non-smoking subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female Japanese subjects between the ages of 18 and 55 years, inclusive.\n* Japanese defined as being able to document that all 4 grandparents were Japanese and were born in Japan.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n* Females of childbearing potential.\n* Subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. Subjects with urine cotinine concentrations \\>100 ng/mL at any time during the study will be excluded.'}, 'identificationModule': {'nctId': 'NCT01396135', 'briefTitle': 'A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Randomized, Subject- And Investigator-blind, Sponsor-open, Placebo-controlled, Single- And Multiple-dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Cp-601,927 In Healthy Japanese Subjects', 'orgStudyIdInfo': {'id': 'A3331019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dosing', 'description': 'Single doses of CP-601,927 (1, 2 or 3 mg) or placebo', 'interventionNames': ['Drug: CP-601,927', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple dosing', 'description': 'Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo', 'interventionNames': ['Drug: CP-601,927', 'Drug: Placebo']}], 'interventions': [{'name': 'CP-601,927', 'type': 'DRUG', 'description': 'Single dose of 1 mg CP-601,927 given as oral 1 mg tablets', 'armGroupLabels': ['Single dosing']}, {'name': 'CP-601,927', 'type': 'DRUG', 'description': 'Single dose of 2 mg CP-601,927 given as oral 1 mg tablets', 'armGroupLabels': ['Single dosing']}, {'name': 'CP-601,927', 'type': 'DRUG', 'description': 'Single dose of 3 mg CP-601,927 given as oral 1 mg tablets', 'armGroupLabels': ['Single dosing']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single dose of placebo given as a matching number of oral tablets', 'armGroupLabels': ['Single dosing']}, {'name': 'CP-601,927', 'type': 'DRUG', 'description': 'Multiple doses of CP-601,927 given as 2 mg BID (4 mg/day) as oral 1 mg tablets for 7 days', 'armGroupLabels': ['Multiple dosing']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Multiple doses of placebo given as a matching number of oral tablets', 'armGroupLabels': ['Multiple dosing']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}