Safety, Tolerability and Pharmacokinetics of CDD-2101 in Health Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Constipation - Functional

In brief

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.

Key facts

Study ID: NCT06570668
Run by: Centre for Chinese Herbal Medicine Drug Development Limited
People needed: 20
Starts: 2024-05-29
Expected to finish: 2024-07-12
Last updated by the study team: 2024-08-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

An individual must meet all the criteria below to be eligible for participation in this study:
Male or female
Aged 18-65 years (inclusive)
Body weight of 50kg or more
BMI 18.5-29.9 kg/m2 (inclusive)
Normal hepatic: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma glutamyl transferase (GGT) and total bilirubin not elevated more than 1.2-fold above the upper limit of normal (ULN)
Normal renal function: glomerular filtration rate (GFR) ≥ 90 mL/min/1.7m2
Understand the study procedures and agree to participate by providing written informed consent
Be willing and able to comply with all study procedures and restrictions
Be a nonsmoker who has not used tobacco- or nicotine-containing products (e.g., nicotine patch) for at least 6 months before administration of the investigational drug
Be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign assessment performed at the Screening Visit and before administration of the investigational drug
Contraceptive use by men or women should be consistent with local regulations regarding the methods of conception for those participating in clinical study

You may not qualify if…

An individual who meets any of the following criteria will be excluded:
Pregnant, trying to become pregnant or lactating
Use of any prescription, non-prescription drug and investigational drug within 30 days prior to administration of the study drug
Has a substance abuse disorder
Has a history of clinically significant endocrine, gastrointestinal (including motility disorder and intestinal obstruction), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Has a history of cancer (malignancy)
Has a known hypersensitivity to any component of the formulation of CDD-2101, its related compounds or placebo, or allergy to Chinese herbal medicine
Has a history of significant multiple and/or severe allergies (e.g., food, drug or latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
Had major surgery, donated, or lost 1 unit of blood (approximately 500 mL) within 8 weeks before administration of the investigational drug
Diagnosis of bowel disorders based on the Rome IV criteria
Has a history of positive for hepatitis B, hepatitis C or HIV
Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink is approximately equivalent to: beer (354 mL/12 ounces), wine (118 mL/4 ounces), or distilled spirits (29.5 mL/1 ounce)
Has participated in another investigational trial within 4 weeks before the pretrial (Screening) visit. The 4-week window will be derived from the date of the last trial procedure and/or AE related to the trial procedure in the previous trial to the pretrial/Screening Visit of the current trial.
Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the sponsor or Contract Research Organization (CRO)
Having received another investigational drug or been participated in an investigational drug or device study within 30 days before administration of the investigational drug.

Where it is running

Biotrial Inc — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.