A Trial to Assess TEV-56286 at Different Doses in Healthy Participants
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTeva Branded Pharmaceutical Products R&D LLC
About this trial
The purpose of the trial is to evaluate the pharmacokinetics, safety, and tolerability of TEV-56286 at different doses.
The main objective is to describe how TEV-56286 is absorbed, distributed, and removed from the body (the pharmacokinetics) following administration of TEV-56286 in single doses of increasing amounts and multiple doses in healthy participants.
A secondary objective is to assess the safety of TEV-56286 and how well it is tolerated.
The estimated duration for participants in Part 1 with Single Ascending Dose is approximately 58 days; including up to 45 days of screening, a 4-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.
The estimated duration for participants in Part 2 with Multiple Ascending Dose is approximately 64 days; including up to 45 days of screening, a 10-day in-clinic period, and follow-up 8+/-1 days post discharge from the clinical unit.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant is a healthy male or female with a body weight of ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) of 18.5 to 32.0 kg/m2 inclusive.
Participant is 18 to 60 years of age inclusive, at the time of signing the informed consent form (ICF).
A woman of non-child bearing potential (WONCBP) as defined: Female participants who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile, or at least 1 year postmenopausal (no menses for at least 12 months without an alternative medical cause plus an increased concentration of follicle stimulating hormone [FSH] within the menopausal range in women not using hormonal contraception or hormonal replacement therapy).
A woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), used consistently and correctly. The acceptable contraceptive regimens in this trial are: non-hormonal intrauterine device (IUD) used for at least 2 consecutive months prior to dosing and willing to continue until at least 28 days after last dose of investigational medicinal product (IMP), bilateral tubal occlusion, and/or azoospermic partner (vasectomized or due to a medical cause). A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of IMP. The participant must be excluded from participation if the serum pregnancy result is positive.
Disqualifiers
Participant presents with or has a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal system, or presence/history of clinically significant immunological, endocrine, metabolic diseases, neurological, psychiatric, or immunological disorder(s), or a history of any illness that, in the opinion of the Principal Investigator, might pose additional risk to the participant by participation in the trial or confound the results of the trial.
Participant presents with a major trauma or surgery during the 60 days prior to screening or at any time between screening and the first dose of IMP, or surgery scheduled during the trial including follow-up period.
The participant has a history of any malignant disease (except for treated and cured skin basal cell carcinoma at least 12 months prior to screening).
Participant has a known drug hypersensitivity reaction to the active component of IMP, or one of its excipients, or any compound listed as being present in a trial formulation.
Trial design
Design model
Sequential
Treatments tested in this trial
TEV-56286
Drugoral administration
Placebo
Drugmatching placebo
Treatment groups
69 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Group 1: Single Ascending Dose (SAD1)Experimental treatment 2 interventions
Group B: Group 2: Single Ascending Dose (SAD2)Experimental treatment 2 interventions
Group C: Group 3: Single Ascending Dose (SAD3)Experimental treatment 2 interventions
Group D: Group 4: Single Ascending Dose (SAD4)Experimental treatment 2 interventions
Group E: Group 5: Multiple Ascending Dose (MAD1)Experimental treatment 1 intervention
Group F: Group 6: Multiple Ascending Dose (MAD2)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
SAD: Time to maximum observed plasma drug concentration (tmax) of TEV-56286
Time frame
Day 1 to Day 32
SAD: Maximum observed plasma concentration (Cmax) of TEV-56286
Time frame
Day 1 to Day 33
SAD: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of TEV-56286
Time frame
Day 1 to Day 34
SAD: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of TEV-56286
Time frame
Day 1 to Day 3Secondary outcomes
1
Number of participants with at least 1 treatment-emergent adverse event
Time frame
Up to Day 172
Number of participants who did not complete the trial due to an adverse event
Time frame
Up to Day 17Sponsors and contacts
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Source ClinicalTrials.gov