A Clinical Trial of Multiple Formulations of MK-4082 in Healthy Overweight and Obese Participants (MK-4082-007)
A Study to Evaluate the Relative Bioavailability of Multiple Formulations of MK-4082 in Overweight/Obese Participants
Researchers are looking for new weight loss medicines for people with higher body weight. The study medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a study medicine to people with a health condition, researchers first do studies to find a safe dose level (amount) and formulation (version) of the study medicine that can be used in future studies.
The goals of this study are to learn about:
The safety of different formulations of MK-4082 and if people tolerate them What happens to different formulations of MK-4082 in a person's body over time
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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Chula Vista, California, États-Unis, 91911
- ProSciento Inc. ( Site 0002)
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Texas
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San Antonio, Texas, États-Unis, 78232
- ICON Early Phase Services ( Site 0003)
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Is in good health
- Has a body mass index (BMI) between 25 and 40 kg/m^2, inclusive and weighs at least 60 kg
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has a history of previous surgical treatment for obesity that may induce malabsorption, history of bowel resection >20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss
- Has an individual or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Panel A Sequence 1
Participants will be administered daily oral doses of MK-4082 formulation 1 (F1) and MK-4082 formulation 2 (F2) in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F2 for 7 days followed by daily oral doses of MK-4082 F1 for 7 days. |
Oral Tablet Oral Tablet |
|
Expérimental: Panel A Sequence 2
Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 F2 in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F1 for 7 days followed by daily oral doses of MK-4082 F2 for 7 days. |
Oral Tablet Oral Tablet |
|
Expérimental: Panel B Sequence 1
Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 formulation 4 (F4) in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F4 for 7 days followed by daily oral doses of MK-4082 F1 for 7 days. |
Oral Tablet Oral Tablet |
|
Expérimental: Panel B Sequence 2
Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 F4 in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F1 for 7 days followed by daily oral doses of MK-4082 F4 for 7 days. |
Oral Tablet Oral Tablet |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Délai: Up to approximately 8 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. |
Up to approximately 8 weeks
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Délai: Up to approximately 6 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. |
Up to approximately 6 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-4082
Délai: At designated timepoints (up to 24 hours postdose)
|
Blood samples will be collected to determine the AUC0-24 of MK-4082. |
At designated timepoints (up to 24 hours postdose)
|
|
Plasma Concentration at 24 Hours (C24) of MK-4082
Délai: At designated timepoints up to 24 hours postdose
|
Blood samples will be collected to determine the C24 of MK-4082. |
At designated timepoints up to 24 hours postdose
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Medical Director, Merck Sharp & Dohme LLC
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 4082-007
- MK-4082-007 (Autre identifiant: MSD)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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