Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-28 @ 6:12 AM
Study NCT ID:
NCT04857957
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2021-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'CNTX-6016 Effect of Age and Sex in all Cohorts', 'timeFrame': 'Up to Day 14', 'description': 'Systemic exposure to CNTX-6016 By Cmax pooled from all cohorts over full dose range.'}, {'measure': 'CNTX-6016 Effect of Age and Sex in all Cohorts', 'timeFrame': 'Up to Day 14', 'description': 'Systemic exposure to CNTX-6016 By AUC pooled from all cohorts over full dose range.'}, {'measure': 'CNTX-6016 Efficacy - PDN Cohort', 'timeFrame': 'Up to Day 14', 'description': 'Efficacy measured by Numeric Rating Scale. The Numeric Rating Scale is an 11-point pain scale with a range of 0 to 10 where 0 = "no pain" and 10 = "worst possible pain"'}, {'measure': 'CNTX-6016 Efficacy - PDN Cohort', 'timeFrame': 'Up to Day 14', 'description': 'Efficacy measured by PainDETECT Questionnaire'}, {'measure': 'CNTX-6016 Efficacy - PDN Cohort', 'timeFrame': 'Up to Day 14', 'description': 'Efficacy measured by Patient Global Impression of Change'}], 'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016', 'timeFrame': 'Up to 45 days', 'description': 'Number of participants with TEAEs, which includes laboratory test variables'}, {'measure': 'CNTX-6016 Pharmacokinetics - Cmax', 'timeFrame': 'Up to Day 6', 'description': 'Systemic exposure to CNTX-6016 measured by Cmax'}, {'measure': 'CNTX-6016 Pharmacokinetics - AUC0-t', 'timeFrame': 'Up to Day 6', 'description': 'Systemic exposure to CNTX-6016 measured by AUC0-t'}, {'measure': 'CNTX-6016 Pharmacokinetics - t1/2', 'timeFrame': 'Up to Day 6', 'description': 'Systemic exposure to CNTX-6016 measured by t1/2'}, {'measure': 'CNTX-6016 Pharmacokinetics - tmax', 'timeFrame': 'Up to Day 6', 'description': 'Systemic exposure to CNTX-6016 measured by tmax'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Painful Diabetic Neuropathy'], 'conditions': ['Painful Diabetic Neuropathy']}, 'descriptionModule': {'briefSummary': 'A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Is in good general health as determined by Investigator's review.\n* Has a body mass index (BMI) between 18 and 35 kg/m2.\n* Non- or ex-smoker (\\> 1 year) and has not used any nicotine containing products within 12 months prior to screening.\n* For females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control.\n* For males, must agree to use barrier contraception and not to donate sperm\n\nKey Exclusion Criteria:\n\n* Is pregnant, lactating, or planning a pregnancy during the study.\n* Tests positive for COVID-19 after screening is complete and subject is confirmed to enroll\n* History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.\n* Has any history or currently active type of cancer except excised or cured basal cell carcinoma.\n* Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection.\n* Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse\n* Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV).\n\nKey Inclusion Criteria- PDN Cohort\n\n* A diagnosis/history of Type 2 diabetes mellitus\n* The pain is present in both feet/legs with symmetrical onset\n* The pain is characterized as burning, painful, cold or electrical shocks in nature\n* The pain is associated with tingling, numbness, itching or pins and needles type sensations\n* The pain has been present and consistent for ≥ 6 months\n\nKey Exclusion Criteria- PDN Cohort\n\n* Diagnosis of Type 1 diabetes\n* Has serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness\n* Has a history or currently active type of cancer except excised or cured basal cell carcinoma.\n* Has a History of psychological conditions or neurological disorders\n* Has a History of lower back pain with radiculopathy\n* Has received non-pharmacological treatment for pain within 14 days\n* Has a history of frequent and/or severe allergic reactions with multiple medications"}, 'identificationModule': {'nctId': 'NCT04857957', 'briefTitle': 'Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centrexion Therapeutics'}, 'officialTitle': 'A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CNTX-6016 in Healthy Subjects and a Single Cohort of Subjects With Painful Diabetic Neuropathy', 'orgStudyIdInfo': {'id': 'CNTX-6016o-HV/PDN-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Dose 1', 'interventionNames': ['Drug: Oral dose CNTX-6016 or oral dose Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Dose 2', 'interventionNames': ['Drug: Oral dose CNTX-6016 or oral dose Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Dose 3', 'interventionNames': ['Drug: Oral dose CNTX-6016 or oral dose Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PDN cohort', 'description': 'Dose based on safety in healthy Cohorts 1-3', 'interventionNames': ['Drug: Oral dose CNTX-6016 or oral dose Placebo']}], 'interventions': [{'name': 'Oral dose CNTX-6016 or oral dose Placebo', 'type': 'DRUG', 'description': 'CNTX-6016 or Placebo', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'PDN cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'AltaSciences', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Randall Stevens, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centrexion Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centrexion Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}