Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570668
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Safety Tolerability and Pharmacokinetics of CDD-2101 in Health Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1 Safety Tolerability and Pharmacokinetics Study of CDD-2101 in Health Volunteers
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 185-299 kgm2 will be hospitalized and randomized in a 11111 ratio N4group to receive one dose of CDD-2101 at 5 10 15 or 20 g andor 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 eg 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 025 05 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 185-299 kgm2 will be hospitalized and randomized in a 11111 ratio N4group to receive one dose of CDD-2101 at 5 10 15 or 20 g andor 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 baselinerandomization 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 subjects 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 subjects source notes
A sample of the diary is in Appendix 1 The diary is to record the number of bowel openings a sense of completeincomplete 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 025 05 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 ie 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
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 baselinerandomization 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 subjects 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 subjects source notes
A sample of the diary is in Appendix 1 The diary is to record the number of bowel openings a sense of completeincomplete 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 025 05 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None