Constipation - FunctionalPhase 1NCT06570668
Safety, Tolerability and Pharmacokinetics of CDD-2101 in Health Volunteers
A Phase 1 study testing CDD-2101 in people with Constipation - Functional, run by Centre for Chinese Herbal Medicine Drug Development Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- CDD-2101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2024to 12 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Safety, Tolerability and Pharmacokinetics Study of CDD-2101 in Health Volunteers
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.
Read the detailed description
A total of 20 eligible healthy subjects aged 18-65 years, body weight of 50kg or more with a 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.
All subjects will be required to refrain from food containing any of the botanicals in CDD-2101 for at least 3 days prior to randomization.
Each subject will also be required to complete a daily bowel habit diary logging all clinical events during the study. The diary may be completed online using an electronic case report form (eCRF) or by pen and paper. Each subject will be provided with the study diary after the screening visit. Subjects will be instructed to record in the diary every day, including the day admitted to the CPU, and continue until 3 days after the dose of investigational drug.
Study diary will be collected and reviewed for completeness at baseline/randomization, and at the end-of-follow-up visit (Day 3). Authorized study personnel will transcribe all data collected from the physical diaries into eCRF. All information collected from the diaries will be analyzed for primary and secondary endpoints in the study.
All subjects will be instructed about diary completion at every study visit. Documentation that subjects have been appropriately instructed (and re-instructed as necessary) on diary completion should be recorded in the subject's source notes.
Subjects who are not consistent or thorough with study diary completion may receive phone reminders if deemed necessary by the investigators. The authorized study personnel providing phone reminders must document the phone contact process in the subject's source notes.
A sample of the diary is in Appendix 1. The diary is to record the number of bowel openings, a sense of complete/incomplete evacuation, and quality of stool according to the Bristol Stool Form Scale (Appendix 2). The Bristol Stool Form Scale is a medical aid designed to classify stools into seven groups and will be supplied to the subjects.
Bristol Stool Form Scale is defined as 7-point scale in which a score of 1 - separate hard lumps, 2 - sausage shaped but lumpy, 3 - sausage-like with cracks on the surface, 4 - sausage-like but smooth and soft, 5 - soft blobs with clearcut edge, 6 - fluffy pieces with ragged edges ragged edges, and 7 - watery with no solid pieces.
A 12-lead ECG will be performed at pre-dose and 24 h post-dose. Full physical examination will be performed 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, 3-6, 6-9, 9-12 and 12-24 h post-dose. Vital signs will be assessed at 0 (pre-dose), 1, 2, 3, 4, 8, 12 and 24 h post-dose. AEs will be monitored during the study period. Upon completion of the 24 h post-dose procedures, the investigator will confirm that it is safe (i.e., the subject appears healthy) before discharging the participants. All subjects will return for a follow-up visit on Day 4 after the last dose of investigational drug.
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 endpoint will be the pharmacokinetic profile with Cmax, Tmax, AUC from 0 to 24 h post-dose and renal excretion as outcome measures, and bowel movement with the number of CSBM and stool quality based on the Bristol Stool Form Scale as outcome measures.
Available data will be entered in a secure clinical database using eCRF, along with subject information.
- Conditions
- Constipation - Functional
- Being tested
- CDD-2101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDD-2101Drug
All subjects will receive 4 sachets of CDD-2101 and/or placebo at a time based on the computer-generated randomization. An unblinded pharmacist will mix the assigned dose of CDD-2101 and/or placebo with 400 mL of water at 70-80°C, cool it to a comfortable temperature and keep it at room temperature for not longer than 1 h. A blinded study nurse or investigator will dispense the suspension to the assigned subject. The subject will drink it under supervision within 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 5 g of CDD-2101 and 15 g of placebo; | Experimental | CDD-2101 is a botanical drug candidate in granule form, with same formulation as the Chinese herbal medicine MZRW, based on the water extract from six botanical raw materials (in the form of decoction pieces) including Huomarean, Dahuang, Kuxingren, Houpo, Baishao and Zhishi (stir-fried with wheat bran). Dextrin and magnesium stearate are added as excipients.
The placebo is in the form of granules for oral use. The granules are a mixture of color and flavor additives (caramel coloring, riboflavin, citric acid and sucrose octaacetate) with dextrin as an excipient. Receives: Drug: CDD-2101 |
| 10 g of CDD-2101 and 10 g of placebo; | Experimental | CDD-2101 is a botanical drug candidate in granule form, with same formulation as the Chinese herbal medicine MZRW, based on the water extract from six botanical raw materials (in the form of decoction pieces) including Huomarean, Dahuang, Kuxingren, Houpo, Baishao and Zhishi (stir-fried with wheat bran). Dextrin and magnesium stearate are added as excipients.
The placebo is in the form of granules for oral use. The granules are a mixture of color and flavor additives (caramel coloring, riboflavin, citric acid and sucrose octaacetate) with dextrin as an excipient. Receives: Drug: CDD-2101 |
| 15 g of CDD-2101 and 5 g of placebo; | Experimental | CDD-2101 is a botanical drug candidate in granule form, with same formulation as the Chinese herbal medicine MZRW, based on the water extract from six botanical raw materials (in the form of decoction pieces) including Huomarean, Dahuang, Kuxingren, Houpo, Baishao and Zhishi (stir-fried with wheat bran). Dextrin and magnesium stearate are added as excipients.
The placebo is in the form of granules for oral use. The granules are a mixture of color and flavor additives (caramel coloring, riboflavin, citric acid and sucrose octaacetate) with dextrin as an excipient. Receives: Drug: CDD-2101 |
| 20 g of CDD-2101 | Experimental | CDD-2101 is a botanical drug candidate in granule form, with same formulation as the Chinese herbal medicine MZRW, based on the water extract from six botanical raw materials (in the form of decoction pieces) including Huomarean, Dahuang, Kuxingren, Houpo, Baishao and Zhishi (stir-fried with wheat bran). Dextrin and magnesium stearate are added as excipients. Receives: Drug: CDD-2101 |
| 20 g of placebo | Placebo comparator | The placebo is in the form of granules for oral use. The granules are a mixture of color and flavor additives (caramel coloring, riboflavin, citric acid and sucrose octaacetate) with dextrin as an excipient. Receives: Drug: CDD-2101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
potential AEs
based on the changes of vital signs, 12-leads ECG, clinical laboratory results and physical examinations
Measured: 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 outcomes (15)
Maximum plasma concentration [Cmax] - cannabisin B
The marker compounds will be calculated by establishing curves of each analyte.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start29 May 2024
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Chinese Herbal Medicine Drug Development Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570668
- Sponsor's protocol ID
- CDD-2101-P1-6
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Safety, Tolerability and Pharmacokinetics Study of CDD-2101 in Health Volunteers
- ClinicalTrials.gov ID
- NCT06570668
- Acronym / sponsor ID
- CDD-2101-P1-6
- Conditions
- Constipation - Functional
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre for Chinese Herbal Medicine Drug Development LimitedUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 20 eligible healthy subjects aged 18-65 years, body weight of 50kg or more with a 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.
All subjects will be required to refrain from food containing any of the botanicals in CDD-2101 for at least 3 days prior to randomization.
Each subject will also be required to complete a daily bowel habit diary logging all clinical events during the study. The diary may be completed online using an electronic case report form (eCRF) or by pen and paper. Each subject will be provided with the study diary after the screening visit. Subjects will be instructed to record in the diary every day, including the day admitted to the CPU, and continue until 3 days after the dose of investigational drug.
Study diary will be collected and reviewed for completeness at baseline/randomization, and at the end-of-follow-up visit (Day 3). Authorized study personnel will transcribe all data collected from the physical diaries into eCRF. All information collected from the diaries will be analyzed for primary and secondary endpoints in the study.
All subjects will be instructed about diary completion at every study visit. Documentation that subjects have been appropriately instructed (and re-instructed as necessary) on diary completion should be recorded in the subject's source notes.
Subjects who are not consistent or thorough with study diary completion may receive phone reminders if deemed necessary by the investigators. The authorized study personnel providing phone reminders must document the phone contact process in the subject's source notes.
A sample of the diary is in Appendix 1. The diary is to record the number of bowel openings, a sense of complete/incomplete evacuation, and quality of stool according to the Bristol Stool Form Scale (Appendix 2). The Bristol Stool Form Scale is a medical aid designed to classify stools into seven groups and will be supplied to the subjects.
Bristol Stool Form Scale is defined as 7-point scale in which a score of 1 - separate hard lumps, 2 - sausage shaped but lumpy, 3 - sausage-like with cracks on the surface, 4 - sausage-like but smooth and soft, 5 - soft blobs with clearcut edge, 6 - fluffy pieces with ragged edges ragged edges, and 7 - watery with no solid pieces.
A 12-lead ECG will be performed at pre-dose and 24 h post-dose. Full physical examination will be performed 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, 3-6, 6-9, 9-12 and 12-24 h post-dose. Vital signs will be assessed at 0 (pre-dose), 1, 2, 3, 4, 8, 12 and 24 h post-dose. AEs will be monitored during the study period. Upon completion of the 24 h post-dose procedures, the investigator will confirm that it is safe (i.e., the subject appears healthy) before discharging the participants. All subjects will return for a follow-up visit on Day 4 after the last dose of investigational drug.
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 endpoint will be the pharmacokinetic profile with Cmax, Tmax, AUC from 0 to 24 h post-dose and renal excretion as outcome measures, and bowel movement with the number of CSBM and stool quality based on the Bristol Stool Form Scale as outcome measures.
Available data will be entered in a secure clinical database using eCRF, along with subject information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 5 g of CDD-2101 and 15 g of placebo; | Experimental | Drug: CDD-2101CDD-2101 is a botanical drug candidate in granule form, with same formulation as the Chinese herbal medicine MZRW, based on the water extract from six botanical raw materials (in the form of decoction pieces) including Huomarean, Dahuang, Kuxingren, Houpo, Baishao and Zhishi (stir-fried with wheat bran). Dextrin and magnesium stearate are added as excipients. The placebo is in the form of granules for oral use. The granules are a mixture of color and flavor additives (caramel coloring, riboflavin, citric acid and sucrose octaacetate) with dextrin as an excipient. |
| 10 g of CDD-2101 and 10 g of placebo; | Experimental | Drug: CDD-2101CDD-2101 is a botanical drug candidate in granule form, with same formulation as the Chinese herbal medicine MZRW, based on the water extract from six botanical raw materials (in the form of decoction pieces) including Huomarean, Dahuang, Kuxingren, Houpo, Baishao and Zhishi (stir-fried with wheat bran). Dextrin and magnesium stearate are added as excipients. The placebo is in the form of granules for oral use. The granules are a mixture of color and flavor additives (caramel coloring, riboflavin, citric acid and sucrose octaacetate) with dextrin as an excipient. |
| 15 g of CDD-2101 and 5 g of placebo; | Experimental | Drug: CDD-2101CDD-2101 is a botanical drug candidate in granule form, with same formulation as the Chinese herbal medicine MZRW, based on the water extract from six botanical raw materials (in the form of decoction pieces) including Huomarean, Dahuang, Kuxingren, Houpo, Baishao and Zhishi (stir-fried with wheat bran). Dextrin and magnesium stearate are added as excipients. The placebo is in the form of granules for oral use. The granules are a mixture of color and flavor additives (caramel coloring, riboflavin, citric acid and sucrose octaacetate) with dextrin as an excipient. |
| 20 g of CDD-2101 | Experimental | Drug: CDD-2101CDD-2101 is a botanical drug candidate in granule form, with same formulation as the Chinese herbal medicine MZRW, based on the water extract from six botanical raw materials (in the form of decoction pieces) including Huomarean, Dahuang, Kuxingren, Houpo, Baishao and Zhishi (stir-fried with wheat bran). Dextrin and magnesium stearate are added as excipients. |
| 20 g of placebo | Placebo comparator | Drug: CDD-2101The placebo is in the form of granules for oral use. The granules are a mixture of color and flavor additives (caramel coloring, riboflavin, citric acid and sucrose octaacetate) with dextrin as an excipient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- An individual must meet all the criteria below to be eligible for participation in this study:
Key exclusion criteria (15 listed)
- An individual who meets any of the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDD-2101All subjects will receive 4 sachets of CDD-2101 and/or placebo at a time based on the computer-generated randomization. An unblinded pharmacist will mix the assigned dose of CDD-2101 and/or placebo with 400 mL of water at 70-80°C, cool it to a comfortable temperature and keep it at room temperature for not longer than 1 h. A blinded study nurse or investigator will dispense the suspension to the assigned subject. The subject will drink it under supervision within 15 minutes. | Drug | 10 g of CDD-2101 and 10 g of placebo;, 15 g of CDD-2101 and 5 g of placebo;, 20 g of CDD-2101, 20 g of placebo, 5 g of CDD-2101 and 15 g of placebo; |
Primary outcome
potential AEs
Time frame: 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
based on the changes of vital signs, 12-leads ECG, clinical laboratory results and physical examinations
15 secondary outcomes
Maximum plasma concentration [Cmax] - cannabisin B
Time frame: pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose
Maximum plasma concentration [Cmax] - rhein
Time frame: pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose
Maximum plasma concentration [Cmax] - magnolol
Time frame: pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose
Maximum plasma concentration [Cmax] - paeoniflorin
Time frame: pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose
Maximum plasma concentration [Cmax] - albiflorin
Time frame: pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose
Maximum plasma concentration [Cmax] - synephrine
Time frame: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after dose
Maximum urine concentration [Cmax] - cannabisin B
Time frame: pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose
Maximum urine concentration [Cmax] - rhein
Time frame: pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose
Maximum urine concentration [Cmax] - aloe emodin
Time frame: pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose
Maximum urine concentration [Cmax] - amygdalin
Time frame: pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose
Maximum urine concentration [Cmax] - magnolol
Time frame: pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose
Maximum urine concentration [Cmax] - honokiol
Time frame: pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose
Maximum urine concentration [Cmax] - paeoniflorin
Time frame: pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose
Maximum urine concentration [Cmax] - albiflorin
Time frame: pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose
Maximum urine concentration [Cmax] - synephrine
Time frame: pre-dose and at 0-3, 3-6, 6-9, 9-12 and 12-24 hours after dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDD-2101 in people with Constipation - Functional, run by Centre for Chinese Herbal Medicine Drug Development Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
potential AEs (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.