Clinical trial NCT06911567: A Study to Assess New Formulations of TEV-56286
Official title: An Open-Label, Randomized, Crossover Study to Assess the Comparative Bioavailability of New TEV-56286 Formulations Compared to a Reference TEV-56286 Capsule Formulation Following Single-Dose Administration in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants.

The secondary objective is to evaluate the safety and tolerability of TEV-56286.

The planned duration for each participant is approximately 70 days which includes a 45 day screening period.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18.5 kg/m2 to 32.0 kg/m2 (inclusive)
* Females of childbearing potential agree to take appropriate measures to prevent pregnancy during the study
* Males who do not have a documented vasectomy or are not congenitally sterile must agree to abstinence or use of barrier method with spermicide with female partner. Male participant who is having sexual intercourse with a woman of childbearing potential who is not currently pregnant will be advised of her requirement to use an additional highly effective contraceptive method
* NOTE - Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Participation in another clinical trial simultaneously
* Females who are lactating, breastfeeding, or intends to become pregnant over the course of the study
* History of alcohol, drug or any other substance, abuse, addiction or dependence in the last 12 months (except for caffeine)
* Major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of IMP, or surgery scheduled during the study or follow-up period
* Donated blood or blood products (eg, white blood cells \[WBCs\], platelets, etc.) within the 60 days before screening, or has donated blood or blood products at least twice within the 6 months before screening, or has donated plasma within 7 days of the screening visit or has received blood or blood products in the 6 weeks before screening
* Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope, or previous personal treatment for high blood pressure
* NOTE - Additional criteria apply, please contact the investigator for more information

Primary outcomes:
measure: Maximum Observed Drug Concentration (Cmax)
timeFrame: Up to Day 17
measure: Area Under the Drug Concentration-Time Curve from Time 0 to Last Measurable Drug Concentration [AUC(0-t)]
timeFrame: Up to Day 17
measure: Area Under the Drug Concentration-Time Curve from Time 0 to Infinity [AUC(0-inf)]
timeFrame: Up to Day 17
Secondary outcomes:
measure: Number of participants with at least one treatment-emergent adverse event
timeFrame: Up to Day 26
measure: Number of participants who did not complete the trial due to an adverse event
timeFrame: Up to Day 26
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Teva Investigational Site 12141
state: Florida
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D LLC
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: