An Open Label Positron Emission Tomography (PET) Study to Evaluate Dopamine Receptor Occupancy of LB-102 Administered Orally to Healthy Subjects
| PROTOCOL NUMBER | LB-102-002 |
|---|---|
| STUDY PHASE | Phase 1b |
| IND NUMBER | 137581 |
| CONTRACT RESEARCH ORGANIZATION | Target Health Inc. 261 Madison Ave. Floor 24 New York, NY 10016 Phone: (212) 681-2100 |
| INVESTIGATOR NAME | Dr. Dean Wong, MD |
| INSTITUTION NAME | Mallinckrodt Institute of Radiology Washington University School of Medicine 4525 Scott Avenue St Louis MO 63110 Phone: (855) 723-3723 |
| ENROLLMENT SIZE | 16 Healthy Subjects |
| ESTIMATED START DATE | November 2020 |
| ESTIMATED COMPLETION DATE | March 2021 |
Clinical Program Study Design: This is a Phase 1, open label study designed to evaluate the dopamine receptor occupancy in healthy subjects. There will be 4 cohorts consisting of 4 subjects each. Eligible subjects will receive 1 or 2 doses of LB-102 on Day 1: subjects in the final cohort will be dosed for 5 days BID on an inpatient basis. This will be an open label study. Blood samples for PK and safety assessments will be collected at screening, immediately pre-dose, and during/before/after PET scan. Subjects enrolled in the inpatient cohort will be monitored daily. Follow-up after discharge will consist of a phone call the evening of discharge and the next day to check on subjects. This will be an adaptive study and doses in cohorts 2-4 will be determined after PET data from Cohort 1 are obtained.
Additional Information:
- LB-102-002 Protocol [ Clarification Memo #1 , #2, #3 , #4]
- Link to ClinicalTrials.gov entry for Study# LB-102-002
A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LB-102 Administered Orally to Healthy Subjects
| PROTOCOL NUMBER | LB-102-001 |
|---|---|
| STUDY PHASE | Phase 1 |
| IND NUMBER | 137581 |
| CONTRACT RESEARCH ORGANIZATION | Target Health Inc. 261 Madison Ave. Floor 24 New York, NY 10016 Phone: (212) 681-2100 |
| INVESTIGATOR NAME | Lukasz Biernat, MD (cohorts 1 - 4) Leela Vrishabhendra, MD (cohorts 5 - 8) |
| INSTITUTION NAME | Medpace Clinical Pharmacology Unit 5355 Medpace Way Cincinnati, OH 45227 Phone: (513) 579-9911 |
| ENROLLMENT SIZE | Single Ascending Dose (SAD): 40 Multiple Ascending Doses (MAD): 24 |
| ESTIMATED START DATE | January 2020 |
| ESTIMATED COMPLETION DATE | August 2020 |
Clinical Program Study Design: This is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of LB-102 in healthy subjects. The study will consist of two parts: Part A – Single Ascending Dose and Part B – Multiple Ascending Doses (ie. SAD & MAD). There will be 5 cohorts in Part A and 3 Cohorts in Part B of this study. Each cohort consists of 8 subjects, with 6 subjects assigned to LB-102 treatment and 2 subjects assigned to placebo treatment.
Additional Information:
- LB-102-001 Investigator’s Brochure
- LB-102-001 Protocol [ Clarification Memo #1, #2, #3, #4, #5, #6, #7 , #8 , #9, #10]
- LB-102-001 Synopsis
- LB-102-002 Bioanalytical Lab Method Validation
- LB-102 Non-Clinical Pharmacology Introduction (excerpted from IND)
- LB-102 Pharmacology In Vivo / In Vitro Summary (excerpted from IND)
- LB-102 Toxicology Summary (excerpted from IND)
- Link to ClinicalTrials.gov entry for Study# LB-102-001
Results:
- LB-102-001 Clinical Study Report (Final)
- LB-102-001 AE Listings
- Sample Analysis of LB-102 and LB-101 in Human Plasma Samples
- Pharmacokinetic Report
Please note that both the Investigator’s Brochure and Protocol are likely to be amended from time to time until the completion of the study. We will endeavor to update the file(s) whenever amendments are made but cannot guarantee the timeliness of updating this website.
