Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-10 @ 9:10 PM
Study NCT ID:
NCT02300350
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2014-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DDI Study With Multiple-dose LX4211 and Single Dose Digoxin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-08', 'studyFirstSubmitDate': '2014-11-20', 'studyFirstSubmitQcDate': '2014-11-24', 'lastUpdatePostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': 'Day 1-Day 7, Day 20-26'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Day 1-Day 26'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple dose LX4211 (400 mg administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 × 0.25-mg tablets) in healthy male and female subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects ≥18 to ≤55 years of age\n* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm\n* Body mass index (BMI) ≥18 and ≤32 kg/sq m\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results\n* History of clinically significant arrhythmias\n* History of cardiac arrhythmias or palpitations associated with presyncope, syncope, or a family history of sudden cardiac death\n* Use of any medications or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study\n* Receipt of any investigational agent or study drug within 30 days prior to Screening\n* Receipt of any protein- or antibody-based therapeutic agents within 3 months prior to Screening\n* Prior exposure to LX4211\n* Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study\n* History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211 or digoxin\n* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211 or digoxin\n* History of any major surgery within 6 months or anticipated surgery prior to Day 1\n* History of any clinically significant hypoglycemia or hyperglycemia\n* History of renal disease, or significantly abnormal kidney function test at Screening\n* History of hepatic disease, or significantly abnormal liver function tests at Screening\n* History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality\n* History of any active infection within 14 days prior to Day 1\n* History of alcohol or substance abuse within 2 years prior to Screening\n* Positive hepatitis panel\n* Donation or loss of \\>500 mL of blood or blood product within 3 months prior to Screening\n* Women who are breastfeeding or are planning to become pregnant during the study, or women who have a positive serum pregnancy test\n* Positive urine glucose at Screening\n* Positive urine screen for drugs of abuse and cotinine at Screening, Day -1, or Day 13\n* Inability or difficulty swallowing whole tablets\n* Unable or unwilling to cooperate with the Investigator for any reason'}, 'identificationModule': {'nctId': 'NCT02300350', 'briefTitle': 'DDI Study With Multiple-dose LX4211 and Single Dose Digoxin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Single-center, Open-label, Two-period, Single-sequence, Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose LX4211 on the Pharmacokinetics of Single-dose Digoxin (Lanoxin®), a Sensitive P-glycoprotein (P-gp) Substrate, in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'LX4211.1-114-NRM'}, 'secondaryIdInfos': [{'id': 'LX4211.114', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': '0.5 mg single-dose oral digoxin administration', 'interventionNames': ['Drug: Treatment A digoxin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': '400 mg oral LX4211 qd administration', 'interventionNames': ['Drug: Treatment B LX4211']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': '0.5 mg single-dose oral digoxin administration + 400 mg oral LX4211 qd administration', 'interventionNames': ['Drug: Treatment C Digoxin + 400 mg LX4211 administered concomitantly']}], 'interventions': [{'name': 'Treatment A digoxin', 'type': 'DRUG', 'description': '0.5 mg digoxin administered on Day 1 and Day 20', 'armGroupLabels': ['Treatment A']}, {'name': 'Treatment B LX4211', 'type': 'DRUG', 'description': '400 mg LX4211 administered daily on Day 14 through Day 25', 'armGroupLabels': ['Treatment B']}, {'name': 'Treatment C Digoxin + 400 mg LX4211 administered concomitantly', 'type': 'DRUG', 'description': '0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20', 'armGroupLabels': ['Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Suman Wason, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lexicon Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lexicon Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}