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The goal of this clinical trial is to learn if BLKR201 is safe in healthy adults. Researchers will also learn how the body absorbs and processes BLKR201 and how food may affect it.
The main questions this study aims to answer are:
Researchers will compare BLKR201 to a placebo (a look-alike tablet that contains no drug) in most parts of the study to see how the drug affects participants.
Participants will:
In one part of the study, a small group of participants will receive BLKR201 only (no placebo). These participants will also have a sample of spinal fluid collected to measure how much BLKR201 reaches the fluid around the brain and spinal cord.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (SAD) Cohorts (BLKR201 or Placebo) | Experimental | Participants receive a single oral dose of BLKR201 or matching placebo in sequential dose-escalation cohorts (up to six escalating doses of BLKR201 to be evaluated) under fasted conditions. One cohort will receive a second dose under fed conditions. Participants are randomized within each cohort. |
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| Multiple Ascending Dose (MAD) Cohorts (BLKR201 or Placebo) | Experimental | Participants receive BLKR201 or matching placebo orally once daily for 7 consecutive days in sequential dose-escalation cohorts (up to four escalating doses of BLKR201 to be evaluated). A twice-daily (BID) cohort may be evaluated based on emerging safety and PK data. Participants are randomized within each cohort. |
|
| Cerebrospinal Fluid (CSF) Cohort (BLKR201, Open-Label) | Experimental | Participants receive BLKR201 orally for 7 consecutive days (planned dose: 200 mg once daily). This cohort is non-randomized and open-label. Cerebrospinal fluid samples are collected to evaluate central nervous system exposure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLKR201 | Drug | BLKR201 is administered orally as a single ascending dose in the SAD stage. In the food effect cohort, BLKR201 is administered under both fasted and fed conditions in separate periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events are defined as adverse events that begin or worsen after administration of BLKR201 or placebo. Events will be summarized by frequency and severity. | Baseline through approximately 7 days after final dose |
| Change From Baseline in Clinical Laboratory Parameters | Clinical laboratory parameters include hematology, clinical chemistry, coagulation, lipid panel, and urinalysis. Change from baseline values will be summarized at scheduled post-dose assessments. | Baseline through approximately 7 days after final dose |
| Change From Baseline in Systolic Blood Pressure | Systolic blood pressure will be measured in millimeters of mercury (mmHg). Change from baseline will be summarized at scheduled post-dose assessments. | Baseline through approximately 7 days after final dose |
| Change From Baseline in Diastolic Blood Pressure | Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Change from baseline will be summarized at scheduled post-dose assessments. | Baseline through approximately 7 days after final dose |
| Change From Baseline in Pulse Rate | Pulse rate will be measured in beats per minute (bpm). Change from baseline will be summarized at scheduled post-dose assessments. | Baseline through approximately 7 days after final dose |
| Change From Baseline in Respiratory Rate | Respiratory rate will be measured in breaths per minute. Change from baseline will be summarized at scheduled post-dose assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of BLKR201 After Single Oral Dose | Cmax is the highest measured plasma concentration of BLKR201 following a single oral dose. | From predose through approximately 7 days after final dose |
| Area Under the Plasma Concentration-Time Curve (AUC) of BLKR201 After Single Oral Dose |
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Inclusion Criteria:
Women who can become pregnant must:
Men with partners who can become pregnant must:
Exclusion Criteria:
Additional exclusions:
For the spinal fluid (CSF) portion of the study, you cannot take part if you:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Recruiting | Lincoln | Nebraska | 68502 | United States |
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Open-label for CSF cohort only
| BLKR201 | Drug | BLKR201 is administered orally once daily for 7 consecutive days in the MAD stage. A twice-daily schedule may be evaluated in a separate cohort if supported by emerging data. |
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| BLKR201 | Drug | BLKR201 is administered orally once daily for 7 consecutive days in the CSF cohort. Dosing frequency may be adjusted based on PK findings. |
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| Placebo | Drug | A matching placebo tablet administered orally, corresponding to the dose level and dosing condition of BLKR201 in each assigned cohort. |
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| Baseline through approximately 7 days after final dose |
| Change From Baseline in Body Temperature | Body temperature will be measured in degrees Fahrenheit (°F). Change from baseline will be summarized at scheduled post-dose assessments. | Baseline through approximately 7 days after final dose |
| Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters | ECG parameters include QT interval corrected using Fridericia's formula (QTcF), PR interval, QRS duration, and heart rate. Change from baseline values will be summarized at scheduled post-dose assessments. | Baseline through approximately 7 days after final dose |
Area under the plasma concentration-time curve (AUClast and AUCinf) will be calculated using non-compartmental analysis to describe overall drug exposure. |
| From predose through approximately 7 days after final dose |
| Maximum Observed Plasma Concentration (Cmax) After Multiple Doses | Cmax at steady state will be calculated after repeated daily dosing. | From predose through approximately 7 days after final dose |
| Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCtau) After Multiple Doses | AUCtau will be calculated to describe total drug exposure during a dosing interval after repeated dosing. | From predose through approximately 7 days after final dose |
| BLKR201 Concentration in Cerebrospinal Fluid (CSF) | BLKR201 concentrations will be measured in cerebrospinal fluid to assess central nervous system exposure. | Day 7 post-dose in the CSF cohort (single CSF sampling time point per participant) |
| Amount of BLKR201 Excreted in Urine | The amount of BLKR201 excreted in urine will be calculated over defined collection intervals. | From predose through 48 hours post-dose (in certain SAD cohorts only) |
| Ratio of Maximum Observed Plasma Concentration (Cmax) of BLKR201 Under Fed Versus Fasted Conditions | The ratio of Cmax under fed and fasted conditions will be calculated to evaluate the effect of a high-fat meal on BLKR201 exposure. | From predose through 48 hours post-dose (in certain SAD cohorts only) |
| Ratio of Area Under the Plasma Concentration Versus Time Curve (AUC) of BLKR201 Under Fed Versus Fasted Conditions | The ratio of AUC under fed and fasted conditions will be calculated to evaluate the effect of a high-fat meal on BLKR201 exposure. | From predose through 48 hours post-dose (in certain SAD cohorts only) |