Safety, Tolerability and Pharmacokinetics of CDD-2101 in Health Volunteers
NCT Number: NCT06570668
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Constipation - Functional
Interventions: DRUG: CDD-2101
Sponsor: Centre for Chinese Herbal Medicine Drug Development Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-29
Completion Date: 2024-07-12
Locations: Biotrial Inc, Newark, New Jersey, 07103, United States

Summary:
This is a single-center, randomized, double-blind, placebo-controlled, single-dose study to confirm the safety, tolerability and pharmacokinetic profile of CDD-2101 in healthy subjects. A total of 20 subjects aged 18-65 years with a Body Mass Index (BMI) of 18.5-29.9 kg/m2 will be hospitalized and randomized in a 1:1:1:1:1 ratio (N=4/group) to receive one dose of CDD-2101 at 5, 10, 15 or 20 g and/or placebo by taking a suspension in water orally. Subjects will complete a daily bowel habit diary 7 days and refrain from food containing any of the botanicals in CDD-2101 for at least 3 days prior to randomization. Subjects will also need to abstain from the consumption of any xanthine containing products (e.g. coffee, tea, chocolate, or Coca-Cola like drinks) more than 6 cups per day (or equivalent) 24 hours before randomization. A 12-lead electrocardiogram (ECG) and a full physical examination will be performed at pre-dose and 24 h post-dose. Blood samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 h post-dose. Urine samples will be collected immediately before and at 0-3 h, 3-6 h, 6-9 h, 9-12 h and 12-24 h post-dose. Vital signs will be measured at 0 (pre-dose), 1, 2, 3, 4, 8, 12 and 24 h post-dose. Adverse events (AEs) will be monitored during the study period. After the 24 h post-dose procedures are completed, the investigator will confirm the subjects are in good health before discharging them. All subjects will have a follow-up visit 3 days after the dose of investigational drug. Plasma samples will be analyzed for complete blood count, liver and kidney function markers, total cholesterol, glucose, calcium and marker compounds of CDD-2101. Urine samples will be processed for quantitation of marker compounds of CDD-2101. The primary endpoint will be safety and tolerability of CDD-2101, with vital signs, reported number and seriousness of AEs, physical examination, and laboratory tests as outcome measures. The secondary endpoints will be the pharmacokinetic profile, with outcome measures including peak plasma concentration (Cmax), time to reach Cmax (Tmax), area under the curve (AUC) from 0 to 24 h post-dose and renal excretion of marker compounds, and bowel movement with the number of complete spontaneous bowel movement (CSBM) and stool quality based on the Bristol Stool Form Scale as outcome measures.

Primary Outcome Measures: potential AEs, based on the changes of vital signs, 12-leads ECG, clinical laboratory results and physical examinations, baseline, pre-intervention, randomization, follow-up 4 days after randomization, through study completion, i.e. from screening till complete follow up visit which is about 26 days
Secondary Outcome Measures: Maximum plasma concentration [Cmax] - cannabisin B, The marker compounds will be calculated by establishing curves of each analyte., pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose|Maximum plasma concentration [Cmax] - rhein, The marker compounds will be calculated by establishing curves of each analyte., pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose|Maximum plasma concentration [Cmax] - magnolol, The marker compounds will be calculated by establishing curves of each analyte., pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose|Maximum plasma concentration [Cmax] - paeoniflorin, The marker compounds will be calculated by establishing curves of each analyte., pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose|Maximum plasma concentration [Cmax] - albiflorin, The marker compounds will be calculated by establishing curves of each analyte., pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose|Maximum plasma concentration [Cmax] - synephrine, The marker compounds will be calculated by establishing curves of each analyte., pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose|Maximum urine concentration [Cmax] - cannabisin B, The marker compounds will be calculated by establishing curves of each analyte., pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose|Maximum urine concentration [Cmax] - rhein, The marker compounds will be calculated by establishing curves of each analyte., pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose|Maximum urine concentration [Cmax] - aloe emodin, The marker compounds will be calculated by establishing curves of each analyte., pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose|Maximum urine concentration [Cmax] - amygdalin, The marker compounds will be calculated by establishing curves of each analyte., pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose|Maximum urine concentration [Cmax] - magnolol, The marker compounds will be calculated by establishing curves of each analyte., pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose|Maximum urine concentration [Cmax] - honokiol, The marker compounds will be calculated by establishing curves of each analyte., pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose|Maximum urine concentration [Cmax] - paeoniflorin, The marker compounds will be calculated by establishing curves of each analyte., pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose|Maximum urine concentration [Cmax] - albiflorin, The marker compounds will be calculated by establishing curves of each analyte., pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose|Maximum urine concentration [Cmax] - synephrine, The marker compounds will be calculated by establishing curves of each analyte., pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose