- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05696483
Phase 1 Study of OLX-07010 in Healthy Adult and Elderly Participants
July 11, 2023 updated by: Oligomerix, Inc
Phase 1 Randomized, Double-Blind, Single Ascending Dose, Multiple Ascending Dose, and Food Effect Study of the Safety, Tolerability, and Pharmacokinetics of OLX-07010 in Healthy Adult and Elderly Participants
This First-in-human (FIH) study will evaluate the safety, tolerability, and pharmacokinetics of the tau self-association inhibitor, OLX-07010 in single ascending doses (SAD) and multiple ascending doses (MAD) in healthy adults (18-50 of age inclusive), and single dose in healthy elderly (51-75 of age inclusive).
The effects of dosing with or without food in healthy adults will also be studied (optional).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This FIH Phase 1 randomized, double-blind, four-part study will be conducted to evaluate the safety, tolerability, and PK of the tau self-association inhibitor, OLX-07010 in single ascending doses, multiple ascending doses in healthy adult participants, and as a single dose in healthy elderly participants.
There is an option for an additional part to evaluate the effects of food (fed and fasted) on OLX-07010 in healthy adult participants.
This study will be divided into 4 parts: Part 1-Randomized Double-Blind Single Ascending Dose in Healthy Adult Participants; Part 2-Randomized Double-Blind Multiple Ascending Dose in Healthy Adults Participants; Part 3-Randomized Double-Blind Single Dose in Healthy Elderly Participants; and Part 4 (Optional)-Food Effect (Single Cohort, 2 Sequence, 2 Period Crossover Fed and Fasted) in Healthy Adult Participants.
Study Type
Interventional
Enrollment (Estimated)
88
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Glendale, California, United States, 91206
- California Clinical Trials Medical Group, Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participant voluntarily agrees to participate and signs an approved informed consent prior to performing any of the Screening Visit procedures.
- Participant must be a healthy male or female of non-childbearing potential 18 to 50 years old inclusive, in Part 1, 2, and 4 of the study. Participant must be a healthy elderly male or female of non-childbearing potential 51-75 years old inclusive in Part 3 of the study.
- Male participants with body weight ≥ 55 kg; and females with body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m2 (inclusive) for Part 1, 2, and 4 of the study; and BMI between 18 and 32 kg/m2 (inclusive) for Part 3 of the study.
- Female participants must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or postmenopausal ≥ 1 year with follicle -stimulating hormone [FSH] > 40 IU/L at screening).
Exclusion Criteria:
- Participant has clinically significant history or evidence of cardiovascular (CV), respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s).
- Participant has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
- Participant has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.
- Treatment with any investigational drug within the past 30 days prior to dosing.
- Use of any prescription drugs, herbal supplements, within 30 days prior to initial dosing, and over the counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing. For elderly population in Part 3, allowed medications must be stable for at least 1 month.
- Clinically significant vital signs or ECG abnormality at screening and at baseline.
- Score of "yes" on specific items of the Suicidal Ideation section of the C-SSRS at the Screening Visit.
- History of any cancer within 5 years of screening (more than 10 years in remission).
- Any history of renal injury/kidney disease or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or blood urea nitrogen (BUN) values in blood, or clinically relevant abnormal urinary constituents at Screening or Admission.
- Participant has any of the liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma glutamyl transferase [GGT]) or total bilirubin [TBL]) greater than the upper limit of normal (ULN), with the exception of isolated TBL elevation consistent with Gilbert's disease.
- Participants taking medications that are sensitive substrates for CYPC8, CYP2C19, CYP3A4, CYP1A2, and CYP2C9.
- Participant has a significant history of hypersensitivities or allergies to any medications, as determined by the PI/designee.
- Sexually active males not willing to use a condom during intercourse while taking the study drug and until EOS visit.
- Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant.
- Female participants are breastfeeding or female participants with a positive serum pregnancy test at the screening visit or positive urine pregnancy test at admission.
- Participants has poor venous access.
- Participant has history of alcohol and/or illicit drug abuse within 12 months prior dosing or positive alcohol/illicit drug test at screening and/or admission; smoking history (use of tobacco products in the previous 3 months prior dosing) or positive cotinine test at screening or admission.
- Participant has donated blood (> 500 mL) or blood products within 2 months prior to admission (Day -1). Plasma donation (> 200 mL) within 7 days prior to first dosing.
- Participant has previously been enrolled in this clinical study.
- Participant has a positive reverse transcription polymerase chain reaction (RT PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Participant has clinical signs and symptoms consistent with SARS-CoV-2 infection, e.g., fever, dry cough, dyspnea, sore throat, fatigue, or laboratory confirmed acute infection with SARS-CoV-2.
- Participant who had a severe course of COVID-19; (extracorporeal membrane oxygenation, mechanically ventilated, or Intensive Care Unit stay).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active
Active OLX-07010 in single ascending and multiple ascending dose cohorts
|
25 and 75 mg capsules
|
Placebo Comparator: Placebo
OLX-07010 placebo in single ascending and multiple ascending dose cohorts
|
25 and 75 mg capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events as Measured by NCI-CTCAE criteria
Time Frame: After each dose of OLX-07010 through completion of dosing, up to 30 days
|
Safety and tolerability of OLX-07010 will be assessed by documenting adverse events occurring after single dose administration (Parts 1, 3 and 4) and multiple dose administration (Part 2)
|
After each dose of OLX-07010 through completion of dosing, up to 30 days
|
Incidence of Treatment-Emergent Adverse Events as Measured by Clinical Laboratory Measurements According to Established Clinical Normal Ranges
Time Frame: Change from baseline at 2-4 hours post-dose of OLX-07010
|
Blood and Urine samples will be taken after administration of OLX-07010 and values will be compared to baseline and established normal ranges to determine how OLX-07010 administration impacts normal body function
|
Change from baseline at 2-4 hours post-dose of OLX-07010
|
Incidence of Treatment-Emergent Adverse Events as Measured by ECG
Time Frame: Change from baseline at 2, 4, and 8 hours and Days 2 and 4 post-dose of OLX-07010
|
ECGs will be used to measure changes to the heart after administration of OLX-07010
|
Change from baseline at 2, 4, and 8 hours and Days 2 and 4 post-dose of OLX-07010
|
Incidence of Treatment-Emergent Adverse Events as Measured by Neurological Examination
Time Frame: Change from baseline at Day 1, Day 4 (Parts 1 and 3) and Days 7 and 10 (Parts 2 and 4) post-dose of OLX-07010
|
Neurological assessments will be performed to investigate the potential effect of the study drug on mental status, gait (normal/abnormal), coordination/incoordination, tremor, muscle tone, stereotypy and biceps reflexes
|
Change from baseline at Day 1, Day 4 (Parts 1 and 3) and Days 7 and 10 (Parts 2 and 4) post-dose of OLX-07010
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum drug concentration in plasma (Cmax) of OLX-07010 after single ascending doses
Time Frame: Blood collection on Day 1, 2, 3, and 4. On Day 1 (pre-dose 0 hour, post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, and 12 hours), Day 2 (24 hours post-dose), Day 3 (48 hours post-dose) and Day 4 (72 hours post-dose).
|
The maximum drug concentration will be determined after a single ascending doses
|
Blood collection on Day 1, 2, 3, and 4. On Day 1 (pre-dose 0 hour, post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, and 12 hours), Day 2 (24 hours post-dose), Day 3 (48 hours post-dose) and Day 4 (72 hours post-dose).
|
Maximum drug concentration in plasma (Cmax) of OLX-07010 after multiple ascending doses
Time Frame: Day 1and Day 7 (pre-dose 0 hour, and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, 12 hours), Days 2 (24 hours post-dose) to Day 6 (pre-dose 0 hours), Day (24 hours post-dose), Day 9 (48 hours post-dose), and Day 10 (72 hours post-dose).
|
The maximum drug concentration will be determined after a single ascending doses
|
Day 1and Day 7 (pre-dose 0 hour, and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, 12 hours), Days 2 (24 hours post-dose) to Day 6 (pre-dose 0 hours), Day (24 hours post-dose), Day 9 (48 hours post-dose), and Day 10 (72 hours post-dose).
|
Area under the concentration-time curve in plasma (AUC) of OLX-07010 after single ascending doses.
Time Frame: Blood collection on Day 1, 2, 3, and 4. On Day 1 (pre dose 0 hour, post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, and 12 hours), Day 2 (24 hours post-dose), Day 3 (48 hours post-dose) and Day 4 (72 hours post-dose).
|
Determine the Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) and from pre-dose (time 0) extrapolated to infinite time (AUClast + Clast/λz) calculated using the linear-log trapezoidal rule.
|
Blood collection on Day 1, 2, 3, and 4. On Day 1 (pre dose 0 hour, post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, and 12 hours), Day 2 (24 hours post-dose), Day 3 (48 hours post-dose) and Day 4 (72 hours post-dose).
|
Area under the concentration-time curve in plasma (AUC) of OLX-07010 after multiple ascending doses.
Time Frame: Day 1and Day 7 (pre-dose 0 hour, and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, 12 hours), Days 2 (24 hours post-dose) to Day 6 (pre-dose 0 hours), Day (24 hours post-dose), Day 9 (48 hours post-dose), and Day 10 (72 hours post-dose).
|
Determine the Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) and from pre-dose (time 0) extrapolated to infinite time (AUClast + Clast/λz) calculated using the linear-log trapezoidal rule.
|
Day 1and Day 7 (pre-dose 0 hour, and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, 7, 9, 12 hours), Days 2 (24 hours post-dose) to Day 6 (pre-dose 0 hours), Day (24 hours post-dose), Day 9 (48 hours post-dose), and Day 10 (72 hours post-dose).
|
Renal clearance and percent drug excreted in Urine after single and multiple ascending doses of OLX-07010.
Time Frame: Part 1:Day 1 at 0 hour (pre-dose), 0-4; 4-8; 8-12; and 12-24 hours post-dose. Part 2: Day 1 and Day 7 at 0 hour (pre-dose), 0-4 hours; 4-8 hours; 8-12 hours; 12-24 hours.
|
Determine the the renal clearance and amount of OLX-07010 excreted in urine.
|
Part 1:Day 1 at 0 hour (pre-dose), 0-4; 4-8; 8-12; and 12-24 hours post-dose. Part 2: Day 1 and Day 7 at 0 hour (pre-dose), 0-4 hours; 4-8 hours; 8-12 hours; 12-24 hours.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
December 13, 2022
First Submitted That Met QC Criteria
January 23, 2023
First Posted (Actual)
January 25, 2023
Study Record Updates
Last Update Posted (Actual)
July 12, 2023
Last Update Submitted That Met QC Criteria
July 11, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OLX-07010-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on OLX-07010 Active
-
Unilever R&DCompleted
-
Novozymes A/SAnalyze & RealizeNot yet recruiting
-
Case Western Reserve UniversityHighland Instruments, Inc.RecruitingDiabetic Neuropathies | Chronic PainUnited States
-
University of California, Los AngelesRecruiting
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH); United States...CompletedChronic Low Back Pain | Chronic Neck PainUnited States
-
Chang Gung Memorial HospitalEnrolling by invitationSuspected Non-Alzheimer Disease Pathophysiology (SNAP)Taiwan
-
Lund UniversityVinnova; Antidiabetic Food Centre AFCCompleted
-
University Health Network, TorontoPatient-Centered Outcomes Research Institute; M.D. Anderson Cancer Center; Applied... and other collaboratorsActive, not recruitingDysphagiaUnited States, Canada
-
Sophiahemmet UniversityKarolinska Institutet; Linnaeus University; The Swedish School of Sport and Health... and other collaboratorsNot yet recruiting
-
University of California, Los AngelesUCLA Vatche and Tamar Manoukian Division of Digestive Diseases; UCLA Department...CompletedColorectal Neoplasms | Colorectal Cancer | Health ScreeningUnited States