A Phase 1 interventional study of CC100 and Placebos in Amyotrophic Lateral Sclerosis, sponsored by Chemigen, LLC. Status unknown at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2017-08-03.
Sponsored by Chemigen, LLC · Phase 1, Interventional, and Treatment
Approximately 21 subjects with amyotrophic lateral sclerosis (ALS) will be randomized (6 to 1) to receive by mouth seven morning doses of CC100 or placebo for 7 days. Subjects are required to stay in the Clinic for approximately 9 hours following the first and last dose. Subjects will also have a mid-week clinic visit and will be contacted by phone within 3 to 5 days after the last dose.
Funding Source - FDA OOPD
Primary objective: to assess the safety and tolerability of multiple doses of orally administered CC100 in subjects with amyotrophic lateral sclerosis (ALS). Secondary objectives: to determine pharmacokinetics and pharmacodynamics of CC100 in plasma after single and after multiple doses; and to determine short-term effects of CC100 on potential blood-cell ALS biomarkers.
Study Design: Phase 1 double-blind, randomized, placebo-controlled multiple-dose of three CC100-dose cohorts. Approximately 18 subjects will receive CC100. Approximately 3 subjects will be randomized to placebo (across 3 cohorts). Periodic Assessment Committee safety reviews. Note: Participation will not exclude subjects from future CC100 studies Criteria for Evaluation: Safety Endpoints: Adverse events, blood chemistry, hematology, urinalysis, vital signs, 12-lead ECGs. Pharmacokinetic (PK)/Pharmacodynamic (PD): Plasma for CC100 concentrations (PK). Blood collected at baseline and after each subject's last dose will be assayed for potential biomarker(s). Stored specimens will be de-identified or combined for validating diagnostic tools/assays related to ALS. Statistical Methods: A minimum of 6 subjects per CC100 dose group and 3 placebo-dosed subjects (total across cohorts) are considered sufficient to evaluate initial safety and tolerability for the cohorts. Pharmacokinetic parameter estimates will be calculated by standard noncompartmental methods of analysis. Absolute bioavailability of administration will be estimated based on the total area under the time- concentration curve (AUC0-∞).
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's planned enrollment of 21 is below the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →Chemigen, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
CC100 250 mg once daily by mouth for 7 days
Drug: CC100
CC100 500 mg once daily by mouth for 7 days
Drug: CC100
CC100 1000 mg once daily by mouth for 7 days
Drug: CC100
Placebo once daily by mouth for 7 days
Drug: Placebos
synthetic caffeic acid phenethylester
Also known as: synthetic caffeic acid phenethylester
Diluent
Also known as: Placebo oral liquid
Safety and Tolerability: Adverse events, safety labs, vital signs, and ECGs
Safety and tolerability assessed by group/dose measured by number of unsolicited adverse events (MedDRA), and changes in blood chemistry, hematology, urinalysis, vital signs, and 12-lead ECGs from baseline (prior to dosing).
Time frame: From start of first dose to a minimum of 3 days after last dose
Pharmacokinetics (PK)--Peak plasma concentration (Cmax)
Cmax after first (single) and last (multiple) CC100 doses
Time frame: 0.5, 1, 2, 4, and 8 hours after first and last dose
Pharmacokinetics (PK)--Area under the plasma concentration versus time curve (AUC)
AUC after first (single) and last (multiple) CC100 doses
Time frame: 0.5, 1, 2, 4, and 8 hours after first and last dose
Pharmacokinetics (PK)--Half life (T 1/2)
Estimated half-life after first (single) and last (multiple) CC100 doses
Time frame: 0.5, 1, 2, 4, and 8 hours after first and last dose
Pharmacodynamics (PD)--Monocyte chemotactic protein 1 (MCP-1)
Short-term effects of CC100 on potential ALS inflammation biomarker MCP-1
Time frame: Pretreatment and 8 hours post last dose
Pharmacodynamics (PD)--Excitotoxicity/oxidative stress biomarkers
Short-term effects of CC100 on potential ALS excitotoxicity/oxidative stress biomarkers: Heme oxygenase-1 (HMOX-1)/thioredoxin (TRX)/heat-shock protein 70 (HSP-70)
Time frame: Pretreatment and 8 hours post last dose
Plan to share: No — Single-site study
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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Chemigen, LLC