Health TrialsbyHealthPanel

Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAbivax S.A.

About this trial

The sponsor is developing a pediatric minitablet formulation as part of the overall pharmaceutical development strategy. In vitro dissolution and physiological-based bio-pharmaceutics modelling and simulation have been used to guide the development of the mini-tablet formulation to match the PK exposure of the adult capsule formulation. The study aims to investigate the relative bioavailability of the 50mg minitablet compared to the adult obefazimod 50 mg capsule in adult healthy volunteers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 55 years inclusive at the time of signing informed consent

Must agree to adhere to the contraception requirements.

Healthy male or non-pregnant, non-lactating female participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG and laboratory safety tests without any clinically significant abnormalities

Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening

Disqualifiers

Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.

History of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator

Participants with a history of cholecystectomy or gall stones

Participants with chronic or recurrent infection

Trial design

Design model

Crossover

Treatments tested in this trial

  • Obefazimod 50 mg Capsule

    Drug

    Adult formulation

  • Obefazimod Minitablet 50 mg

    Drug

    Pediatric formulation

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Obefazimod 50 mg Capsule Adult FormulationExperimental treatment 1 intervention
Group B: Obefazimod Minitablet 50 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Plasma Concentration (Cmax)

Cmax of obefazimod in the Minitablet and Capsule regimens

Time frame
Up to 336 hours post-dose (Day 15) at each period
2

Area under the plasma concentration versus time curve from time zero up to the last measurable concentration (AUC (0-last)

AUC (0-last) of obefazimod in the Minitablet and Capsule regimens

Time frame
Up to 336 hours post-dose (Day 15) at each period
3

Area under the plasma concentration versus time curve up from time zero to infinity [AUC(0-inf)]

AUC(0-inf) of obefazimod in the Minitablet and Capsule regimens

Time frame
Up to 336 hours post-dose (Day 15) at each period

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abivax S.A.

Lead sponsor

Quotient Sciences

Collaborator

Source ClinicalTrials.gov
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