Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-29 @ 10:01 AM
Study NCT ID:
NCT02548806
Status:
COMPLETED
Last Update Posted:
2016-04-18
First Post:
2015-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-15', 'studyFirstSubmitDate': '2015-09-02', 'studyFirstSubmitQcDate': '2015-09-10', 'lastUpdatePostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose proportionality of two strengths of clonidine MBT (50μg and 100 μg) as assessed by Non-compartmental pharmacokinetic analysis (Area Under the Curve)', 'timeFrame': '3 Months', 'description': 'To evaluate dose proportionality of two strengths (50 μg and 100 μg) of Clonidine MBT, by using Area Under the Curve (AUC)'}, {'measure': 'Bioavailability of clonidine from Clonidine MBT 50 μg and 100 μg with that from oral clonidine hydrochloride 100 μg tablets. (Area Under the Curve)', 'timeFrame': '3 Months', 'description': 'To compare the bioavailability of clonidine from Clonidine MBT® 50 μg and 100 μg with that from oral clonidine hydrochloride 100 μg tablets, by using Area Under the Curve (AUC)'}], 'secondaryOutcomes': [{'measure': 'General safety information (adverse events, (AEs), 12-lead electrocardiogram (ECG) and vital signs), during the study period.', 'timeFrame': '3 Months', 'description': 'Number of Participants With Treatment-Related Adverse Events as Assessed by Common Toxicity Criteria for Adverse Effects (CTCAE v4.0), 12-lead electrocardiogram (ECG) and vital signs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clonidine'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '28726169', 'type': 'DERIVED', 'citation': 'Vasseur B, Dufour A, Houdas L, Goodwin H, Harries K, Emul NY, Hutchings S. Comparison of the Systemic and Local Pharmacokinetics of Clonidine Mucoadhesive Buccal Tablets with Reference Clonidine Oral Tablets in Healthy Volunteers: An Open-Label Randomised Cross-Over Trial. Adv Ther. 2017 Aug;34(8):2022-2032. doi: 10.1007/s12325-017-0585-9. Epub 2017 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy subjects.', 'detailedDescription': 'A single blind, randomised, 3-period, 3-sequence single-dose crossover study to determine the pharmacokinetic dose proportionality of Clonidine MBT 50 μg and Clonidine MBT 100 μg and comparative bioavailability of clonidine from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy male and female subjects.\n\n36 subjects will be randomised for 30 to complete the study. The study will comprise of 3 Treatment Periods (1, 2 and 3) and a post study follow up (7 - 12 days after the last dose). Study drug will be administered on the morning of Day 1. Pharmacokinetic (PK) blood samples will be collected for each of three treatment periods. Safety will be evaluated at specified times throughout the study. There will be at least 7 days between dose administrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* Healthy males or females (non-pregnant/non-lactating) aged 18 - 50 years.\n* A Body Mass Index (BMI) of 18-30.\n* No clinically significant abnormal serum biochemistry, haematology and urine examination values.\n* A negative urinary drugs of abuse screen.\n* Negative HIV and Hepatitis B and C results.\n* No clinically significant abnormalities in 12-lead electrocardiogram (ECG).\n* No clinically significant abnormalities in blood pressure or pulse.\n* No allergy or sensitivity to clonidine or any of its excipients.\n* No allergy to milk or milk derivatives.\n* Subjects must provide written informed consent to participate in the study\n\nMain Exclusion Criteria:\n\n* Current or past medical condition that might significantly affect the pharmacokinetic or\n* pharmacodynamic response to clonidine.\n* Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days.\n* Pathological condition of the oral cavity that would affect administration via the buccal route.\n* Raynaud's disease or other peripheral vascular disease.\n* Receipt of regular medication within 14 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).\n* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.\n* Symptomatic postural hypotension evident on screening\n* History or evidence of Suicidal Ideation and/or behaviour as determined by using Columbia-Suicide Severity Rating Scale (C-SSRS)"}, 'identificationModule': {'nctId': 'NCT02548806', 'briefTitle': 'Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Valerio Therapeutics'}, 'officialTitle': 'Randomised Single Dose 3 Way Crossover Single Blind Study to Evaluate the Pharmacokinetic Dose Proportionality, Compare the Bioavailability and Safety of Clonidine Mucoadhesive Buccal Tablets (MBT) With Catapres in Normal Healthy Volunteers', 'orgStudyIdInfo': {'id': 'OX2015/28/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clonidine MBT 50µg', 'description': 'Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50µg single dose, Clonidine MBT 100μg single dose ,a single-dose of reference catapres 100μg tablets.', 'interventionNames': ['Drug: Clonidine MBT 50µg']}, {'type': 'EXPERIMENTAL', 'label': 'Clonidine MBT 100µg', 'description': 'Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50μg single dose, Clonidine MBT 100µg single dose ,a single-dose of reference catapres 100μg tablets..', 'interventionNames': ['Drug: Clonidine MBT 100µg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Catapres 100μg', 'description': 'Each subject will receive the following treatments in random order over 3 Treatment Periods (1 treatment/period): Clonidine MBT 50μg single dose, Clonidine MBT 100μg single dose ,a single-dose of reference catapres 100μg tablets.', 'interventionNames': ['Drug: Catapres 100μg']}], 'interventions': [{'name': 'Clonidine MBT 50µg', 'type': 'DRUG', 'otherNames': ['Clonidine Lauriad'], 'description': 'Clonidine MBT 50µg, single dose', 'armGroupLabels': ['Clonidine MBT 50µg']}, {'name': 'Clonidine MBT 100µg', 'type': 'DRUG', 'otherNames': ['Clonidine Lauriad'], 'description': 'Clonidine MBT 100µg, single dose', 'armGroupLabels': ['Clonidine MBT 100µg']}, {'name': 'Catapres 100μg', 'type': 'DRUG', 'otherNames': ['Catapres'], 'description': 'Catapres tablet 100μg, single dose', 'armGroupLabels': ['Catapres 100μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF48 4DR', 'city': 'Merthyr Tydfil', 'country': 'United Kingdom', 'facility': 'Simbec Research Limited', 'geoPoint': {'lat': 51.74794, 'lon': -3.37779}}], 'overallOfficials': [{'name': 'Girish Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simbec Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'presentation at ESMO congress'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valerio Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Simbec Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}