Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-29 @ 3:48 AM
Study NCT ID:
NCT05700734
Status:
WITHDRAWN
Last Update Posted:
2023-03-27
First Post:
2023-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Business Reasons', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-04-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-02-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2023-01-17', 'studyFirstSubmitQcDate': '2023-01-17', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)', 'timeFrame': 'Baseline and 168 hours post-dose', 'description': 'The plasma HIV-RNA will be measured based on a longitudinal data analysis model containing fixed effects for dose level, and dose level by time interaction, and a random effect of MK-8510 (prodrug). The change from baseline for each dose level at 168-hours post baseline will be estimated from this model.'}, {'measure': 'Percentage of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to 36 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.'}, {'measure': 'Percentage of Participants Who Discontinued from Study Due to an Adverse Event (AE)', 'timeFrame': 'Up to 36 days', 'description': 'The percentage of participants who discontinue study due to an AE will be presented.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve of MK-8558 From Time 0 to 168 Hours (AUC0-168 hr)', 'timeFrame': 'At protocol specific timepoints up to 168 hours post-dose', 'description': 'The AUC0-168 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168 hours post-dose.'}, {'measure': 'Area Under the Concentration-Time Curve of MK-8558 From Time 0 to last (AUC0-last)', 'timeFrame': 'At protocol specific time points up to 504 hours post-dose', 'description': 'AUC0-last of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.'}, {'measure': 'Concentration at 168 Hours Post-dose (C168) of MK-8558', 'timeFrame': '168 hours post-dose', 'description': 'C168hr of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated.'}, {'measure': 'Maximum Concentration (Cmax) of MK-8558', 'timeFrame': 'At protocol specific time points up to 504 hours post-dose', 'description': 'Cmax of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of MK-8558', 'timeFrame': 'At protocol specific time points up to 504 hours post-dose', 'description': 'Tmax of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.'}, {'measure': 'Half Life (t1/2) of MK-8558', 'timeFrame': 'At protocol specific time points up to 504 hours post-dose', 'description': 't1/2 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.'}, {'measure': 'Apparent Plasma Clearance of Drug After Extravascular Administration (CL/F) of MK-8558', 'timeFrame': 'At protocol specific time points up to 504 hours post-dose', 'description': 'CL/F of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.'}, {'measure': 'Apparent Volume of Distribution in the Terminal State After Extravascular Administration (Vz/F) of MK-8558', 'timeFrame': 'At protocol specific time points up to 504 hours post-dose', 'description': 'Vz/F of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.'}, {'measure': 'Terminal t1/2 of MK-8558', 'timeFrame': 'At protocol specific time points up to 504 hours post-dose', 'description': 'Terminal t1/2 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1', 'Human Immunodeficiency Virus 1', 'Immunodeficiency Virus Type 1, Human', 'Human Immunodeficiency Virus Type 1']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has HIV-1 infection, and is in good health based on medical history, physical examination, vital signs (VS) measurements, and laboratory safety tests.\n* Has documented HIV-1 positive, as determined by a positive enzyme-linked immunosorbent assay (ELISA) or real-time quantitative polymerase chain reaction (QT-PCR) with confirmation (eg, Western Blot).\n* Is anti-retroviral therapy (ART)-naïve, which is defined as:\n\n 1. Having never received any anti-retroviral agent; or\n 2. ART-experienced but has not received any ART for HIV-1 infection within 60 days; or\n 3. Has received pre-exposure prophylaxis (PrEP) treatment prior to diagnosis of HIV-infection but has not received any PrEP within 30 days.\n* Is willing to receive no other ART prior to Day 11 post-dose of the study.\n* Has a body mass index (BMI) ≤35 kg/m2.\n\nExclusion Criteria:\n\n* Has acute (primary) HIV-1 infection.\n* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.\n* Has remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma).\n* Is mentally or legally incapacitated or has significant emotional problems.\n* Has history of cancer (malignancy).\n* Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e, systemic allergic reaction) to prescription or nonprescription drugs or food.\n* Has positive hepatitis B surface antigen (HBsAg).\n* Has a history of chronic hepatitis C unless there has been documented cure and/or participant with a positive serologic test for hepatitis C virus (HCV) has a negative HCV viral load (VL).\n* Had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.\n* Has participated in another investigational study within 4 weeks.\n* Has a clinically significant abnormality on the electrocardiogram (ECG) performed at the pre-study visit.\n* Has been committed to an institution by way of official or judicial order.\n* Is under the age of legal consent or not capable of giving consent.\n* Does not agree to follow the smoking restrictions as defined by the clinical research unit (CRU).\n* Consumes greater than 3 servings of alcoholic beverages (1 serving is approximately equivalent to: beer \\[354 mL/12 ounces\\], wine \\[118 mL/4 ounces\\], or distilled spirits \\[29.5 mL/1 ounce\\]) per day.\n* Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.\n* Is a regular user of any illicit drugs (not including cannabis) or has an history of drug (including alcohol) abuse within approximately 12 months.'}, 'identificationModule': {'nctId': 'NCT05700734', 'briefTitle': 'MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-retroviral Activity of MK-8510 Monotherapy in Anti-retroviral-naïve HIV-1 Infected Participants', 'orgStudyIdInfo': {'id': '8510-002'}, 'secondaryIdInfos': [{'id': 'MK-8510-002', 'type': 'OTHER', 'domain': 'Merck'}, {'id': '2021-006180-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A: MK-8510 at dose level 1', 'description': 'Single oral dose of MK-8510 administered at dose level 1 (≤1800 mg) following a 10-hour fast. Dose level 1 shall not exceed 1800 mg.', 'interventionNames': ['Drug: MK-8510']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B: MK-8510 at dose level 2', 'description': 'Single oral dose of MK-8510 administered at dose level 2 (≤2200 mg) following a 10-hour fast. Dose level 2 shall not exceed 2200 mg.', 'interventionNames': ['Drug: MK-8510']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C: MK-8510 at dose level 3', 'description': 'Single oral dose of MK-8510 administered at dose level 3 (≤2200 mg) following a 10-hour fast. Dose level 3 shall not exceed 2200 mg.', 'interventionNames': ['Drug: MK-8510']}, {'type': 'EXPERIMENTAL', 'label': 'Panel D: MK-8510 at dose level 4', 'description': 'Single oral dose of MK-8510 administered at dose level 4 (≤2200 mg) following a 10-hour fast. Dose level 4 shall not exceed 2200 mg.', 'interventionNames': ['Drug: MK-8510']}], 'interventions': [{'name': 'MK-8510', 'type': 'DRUG', 'description': 'Single dose of MK-8510 administered as a tablet at a dose up to 2200 mg.', 'armGroupLabels': ['Panel A: MK-8510 at dose level 1', 'Panel B: MK-8510 at dose level 2', 'Panel C: MK-8510 at dose level 3', 'Panel D: MK-8510 at dose level 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}