Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the relative bioavailability and food effect of a single dose of milvexian administered as direct compression (DC) oral tablets and roller compacted (RC) oral tablets compared with milvexian administered as Phase 2 oral capsules (Part 1) and of new concept tablets consisting of a single dose of milvexian administered as oral Tablet 1 and Tablet 2 compared with milvexian administered as Phase 2 oral capsules (Part 3) in healthy participants under fasting and fed conditions; to characterize the pharmacokinetics (PK) of multiple twice daily (BID) doses for 5 days of milvexian administered as DC oral tablets and Phase 2 oral capsules in healthy participants (Part 2) and to assess the effects of dosing time and food timing on the PK of single-dose of milvexian Phase 3 oral tablet formulation in healthy participants (Part 4) and to evaluate the relative bioavailability of a single dose of milvexian administered as oral film-coated DC whole tablets, oral film-coated DC tablets dispersed in water and then mixed with apple sauce, and oral film-coated DC tablets dispersed in water and administered as a suspension using a nasogastric (NG) tube in healthy participants under fasting conditions (Part 5).
Interventions
DRUGMilvexian
Milvexian will be administered orally or via nasogastric route as tablets or capsules.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and on Day -1 of Treatment Period 1. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant, in which case the participant may be included * Body mass index (BMI equals to \[=\] weight/height\^2) between 18 and 30 kilograms per meter square (kg/m\^2) (inclusive), and body weight not less than 50 kg at screening * Healthy on the basis of safety laboratory tests performed at screening and on Day -1 of Treatment Period 1. If the results of the safety laboratory tests are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant except as specified in
Exclusion criteria
2. This determination must be recorded in the participant's source documents and initialed by the investigator * A woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and urine pregnancy test on Day 1 of Treatment Period 1 * Before randomization, a woman must be either: a) Not of childbearing potential defined as: postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level greater than (\>) 40 international units per liter IU/L or milli-international units per milliliter (mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal replacement therapy (HRT), however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; b) Of childbearing potential and; practicing a highly effective method of contraception (failure rate of less than \[\<\] 1 percent \[%\] per year when used consistently and correctly) for at least 3 months prior to the study entry and; agrees to remain on a highly effective method of contraception throughout the study and for at least 34 days after the last dose of study drug * During the study, a man who is sexually active with a woman of childbearing potential or with a woman who is pregnant must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/ film/cream/suppository)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parts 1 and 3: Tmax of Milvexian (Food effect) | Up to 16 months | Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian. |
| Area Under the Plasma Concentration-time Curve of Milvexian from Time Zero to Infinity (AUC [0-Infinity]) | Up to 16 months | AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration. |
| Part 2: Area under the Plasma Concentration-time Curve of Milvexian From Time Zero to Time of Last Quantifiable Concentration (AUC [0-Last]) | Up to 16 months | AUC (0-last) is defined as area under the plasma concentration-time curve of milvexian from time zero to time of last quantifiable concentration after administration. |
| Maximum Observed Analyte Concentration (Cmax) of Milvexian | Up to 16 months | Cmax is defined as maximum observed analyte concentration of milvexian. |
| Parts 1 and 3: AUC (0-Infinity) of Milvexian (Food effect) | Up to 16 months | AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration. |
| Parts 1 and 3: AUC (0-Last) of Milvexian (Food effect) | Up to 16 months | AUC (0-last) is defined as area under the plasma concentration-time curve of milvexian from time zero to time of last quantifiable concentration after administration. |
| Parts 1 and 3: Cmax of Milvexian (Food effect) | Up to 16 months | Cmax is defined as maximum observed analyte concentration of milvexian. |
| Actual Sampling Time to Reach the Maximum Observed Analyte Concentration (Tmax) of Milvexian | Up to 16 months | Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to 16 months | An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. |
Countries
United States
Outcome results
None listed