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| ID | Type | Description | Link |
|---|---|---|---|
| AL-794-806 | Other Identifier | Alios Biopharma Inc. | |
| 2017-004193-34 | EudraCT Number |
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The study was closed as the data received to date did not support continuation of the study.
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The purpose of this study is to evaluate the safety and tolerability (including incidence of central nervous system [CNS] related events such as lightheadedness and dizziness), of multiple oral doses of AL-794 in healthy volunteers (HV). Also, to evaluate the pharmacokinetics of ALS-033719 and ALS-033927 in plasma after multiple oral doses of AL-794 in HV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (AL-794 or Placebo) | Experimental | Participants will receive AL-794 or placebo in 2:1 ratio in Cohorts 1 to 3. AL-794 will be administered at a 100 milligram (mg) loading dose (LD) on the morning of Day 1, followed by a 50 mg maintenance dose (MD) on the evening of Day 1 and twice-daily (BID) on Day 2 through Day 5. The duration of dosing may be extended (maximum duration 10 days), at the discretion of the Sponsor and Principal Investigator (PI). |
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| Part 2 (AL-794 or Placebo) | Experimental | Participants will receive AL-794 or placebo in 2:1 ratio. AL-794 will be administered as 100 mg LD on the morning of Day 1, followed by a 50 mg MD on the evening of Day 1 and BID on Day 2 through Day 5. The duration of dosing may be extended (maximum duration 10 days). Based on the results of Part 1, the duration of dosing may be modified. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-794 | Drug | AL-794 will be administered as tablets orally on Day 1 to Day 5. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence in a participant who received study drug or placebo without regard to possibility of causal relationship. | Up to 40 days |
| Part 1: ALS-033719 Plasma Concentrations | Plasma concentration assessment will be done for ALS-033719 following multiple doses of AL-794. | Predose up to Day 12 |
| Part 2: ALS-033719 Plasma Concentrations | Plasma concentration assessment will be done for ALS-033719 following multiple doses of AL-794. | Predose up to Day 5 |
| Part 1: ALS-033927 Plasma Concentrations | Plasma concentration assessment will be done for ALS-033927 following multiple doses of AL-794. | Predose up to Day 12 |
| Part 2: ALS-033927 Plasma Concentrations | Plasma concentration assessment will be done for ALS-033927 following multiple doses of AL-794. | Predose up to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: ALS-033719 Plasma Concentrations in Healthy Women in Fasted and Fed Conditions | Plasma concentration assessment will be done for ALS-033719, after repeated oral doses of AL-794, in healthy women under fasted and fed conditions. | Predose up to Day 12 |
| Part 1: ALS-033927 Plasma Concentrations in Healthy Women in Fasted and Fed Conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adeep Puri, MD | Hammersmith Medicines Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | NW10 7EW | United Kingdom |
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| ID | Term |
|---|---|
| C038978 | sfericase |
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| Placebo | Drug | Matching placebo tablets will be administered. |
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Plasma concentration assessment will be done for ALS-033927, after repeated oral doses of AL-794, in healthy women under fasted and fed conditions. |
| Predose up to Day 12 |
| Part 1 and Part 2: Time-Matched Q-T Interval Corrected for Heart Rate Using Fridericia Method (QTcF) | The QTcF will be measured by electrocardiogram (ECG). | Up to 40 days |