Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412926
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-05-02
Brief Title:
A Study to Learn About How Much Emodepside Gets Absorbed in the Blood and How Food Affects Its Absorption When Given as a New Type of Tablet to Healthy Participants
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Crossover Treatment Phase 1 Open-label Relative Bioavailability Study to Investigate the Pharmacokinetics Safety and Tolerability of Single Doses of 2 Formulations of Emodepside BAY 44-4400 and to Assess the Effect of Food in Healthy Male and Female Participants
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Onchocerciasis or river blindness is an infectious disease caused by a parasitic worm It spreads through the bite of an infected blackfly Common symptoms include severe itching skin problems and eye problems including permanent blindness
Soil-transmitted helminthiasis is an infection caused by various parasitic worms such as whipworm hookworm and roundworm in the intestines The infection spreads through eggs found in the feces of infected people This contaminates the soil in areas with poor sanitation Common symptoms include stomach pain loose stools loss of blood and proteins delayed development in children and reduced work performance in adults
Researchers are looking for better ways to treat onchocerciasis and soil-transmitted helminthiasis Emodepside is being tested for the treatment of onchocerciasis and soil-transmitted helminthiasis in both men and women It works by activating a protein called SLO-1 which causes paralysis and death of the parasitic worms
The main purpose of this study is to find out if there is a difference in how emodepside gets absorbed in the blood when given as a new tablet compared to the existing tablet as a single dose Researchers also want to find the effect of food on the absorption of the new emodepside tablet
The amount of emodepside in participants blood will be measured at various time points These will be used to calculate and compare the following measurements after a single dose of the new and existing tablet of emodepside without food
The amount of emodepside in participants blood will be measured at various time points These will be used to calculate the Cmax and AUC after a single dose of the new tablet of emodepside with and without food The number of participants who experience medical problems during this study will be documented
During this study participants will receive 2 different types of emodepside tablets These include the newly developed tablet and an existing tablet that has already been used in other clinical studies
At the start of the study the researchers will ask participants about their medical and surgical history They will also perform a health check-up for all participants and pregnancy tests for women
During the study participants will have blood and urine samples taken to check for any medical problems and to measure the amount of emodepside in the blood
The study doctors will confirm that the participants can take part in the study This may take up to 21 days
This study has 3 or 4 periods and contains up to 2 in-house periods of 16 days each
On Day 1 of each period participants will receive the treatments but the order of the treatment will be different
Periods 1 and 2 Each participant will receive a single oral dose of the new or the existing emodepside tablet without food
After Period 2 an initial analysis will be performed This analysis will help decide the doses for the next periods
Period 3 Participants will receive a selected dose of the new emodepside tablet either with or without food
Period 4 optional If needed participants may receive a selected dose of the new emodepside tablet either with or without food The decisions to conduct Period 4 will depend on the results of the initial analysis
Participants will have a total of 6 additional weekly visits to the study site for sample collection after the last period either Period 3 or 4
Participants will attend a follow-up visit to the study site 49 days after taking their last dose for a health check-up
This study will include participants who are healthy and will gain no benefit from taking emodepside However the results of the study will provide useful information to support the further development of the new emodepside tablet The results will also provide information on the emodepside doses to be used in patients who need treatment with emodepside Participants will be closely monitored by the study doctors for any medical problems
Soil-transmitted helminthiasis is an infection caused by various parasitic worms such as whipworm hookworm and roundworm in the intestines The infection spreads through eggs found in the feces of infected people This contaminates the soil in areas with poor sanitation Common symptoms include stomach pain loose stools loss of blood and proteins delayed development in children and reduced work performance in adults
Researchers are looking for better ways to treat onchocerciasis and soil-transmitted helminthiasis Emodepside is being tested for the treatment of onchocerciasis and soil-transmitted helminthiasis in both men and women It works by activating a protein called SLO-1 which causes paralysis and death of the parasitic worms
The main purpose of this study is to find out if there is a difference in how emodepside gets absorbed in the blood when given as a new tablet compared to the existing tablet as a single dose Researchers also want to find the effect of food on the absorption of the new emodepside tablet
The amount of emodepside in participants blood will be measured at various time points These will be used to calculate and compare the following measurements after a single dose of the new and existing tablet of emodepside without food
The amount of emodepside in participants blood will be measured at various time points These will be used to calculate the Cmax and AUC after a single dose of the new tablet of emodepside with and without food The number of participants who experience medical problems during this study will be documented
During this study participants will receive 2 different types of emodepside tablets These include the newly developed tablet and an existing tablet that has already been used in other clinical studies
At the start of the study the researchers will ask participants about their medical and surgical history They will also perform a health check-up for all participants and pregnancy tests for women
During the study participants will have blood and urine samples taken to check for any medical problems and to measure the amount of emodepside in the blood
The study doctors will confirm that the participants can take part in the study This may take up to 21 days
This study has 3 or 4 periods and contains up to 2 in-house periods of 16 days each
On Day 1 of each period participants will receive the treatments but the order of the treatment will be different
Periods 1 and 2 Each participant will receive a single oral dose of the new or the existing emodepside tablet without food
After Period 2 an initial analysis will be performed This analysis will help decide the doses for the next periods
Period 3 Participants will receive a selected dose of the new emodepside tablet either with or without food
Period 4 optional If needed participants may receive a selected dose of the new emodepside tablet either with or without food The decisions to conduct Period 4 will depend on the results of the initial analysis
Participants will have a total of 6 additional weekly visits to the study site for sample collection after the last period either Period 3 or 4
Participants will attend a follow-up visit to the study site 49 days after taking their last dose for a health check-up
This study will include participants who are healthy and will gain no benefit from taking emodepside However the results of the study will provide useful information to support the further development of the new emodepside tablet The results will also provide information on the emodepside doses to be used in patients who need treatment with emodepside Participants will be closely monitored by the study doctors for any medical problems
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508905-26-00 | OTHER | EMA - EU CT Number | None |