A Two-Part, Open-Label, Randomized, Placebo-Controlled, Crossover Study to Assess the Reversal of the Anticoagulant Effects of milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Subjects

A Two-Part, Open-Label, Randomized, Placebo-Controlled, Crossover Study to Assess the Reversal of the Anticoagulant Effects of milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Subjects - Reversal of the Anticoagulant Effects of Milvexian (JNJ-70033093)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54179

Enrollment

Registered

2020-04-07

Start date

2020-08-06

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thromboembolic disorders

Interventions

See Study design

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Participants must be male or female between 18 and =18.0 and

Exclusion criteria

Exclusion criteria: 1. If a woman, pregnant, breast-feeding or planning to become pregnant during the study. 2. History or family history of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study intervention to the subject or that could prevent, limit or confound the protocol specified assessments. 3. Participants with current hepatitis B infection, or hepatitis C infection, or human immunodeficiency virus type1 (HIV-1) or HIV-2 infection at study screening. 4. History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) and known allergy to the study intervention or any of the excipients of the formulations. History of allergy to or unwillingness to consume any component of high-fat breakfast menu to be provided in this study. 5. Any of the following laboratory results outside of the ranges specified below at screening or on Day -1 of Period 1, confirmed by repeat: a. Hemoglobin or hematocrit ULN d. Low-density lipoprotein (LDL), High-density lipoprotein (HDL), apolipoprotein B, or lipoprotein a, outside the normal reference ranges (at the screening visit only) For a complete overview see the protocol

Design outcomes

Primary

Measure	Time frame
To evaluate the reversal of the anticoagulant effects of JNJ-70033093 by 4F-PCC and rFVIIa in healthy subjects as measured by changes from baseline of the coagulation testing parameters (aPTT and TGA).	—

Secondary

Measure	Time frame
To assess the safety and tolerability of 4F-PCC and rFVIIa when co-administered with milvexian to reverse its anticoagulant effects in healthy participants. To assess the pharmacokinetics (PK) of multiple doses of milvexian at 200 mg BID on Days 4 to 7 (Part 1). To assess the pharmacokinetics (PK) of single 100 mg and 500 mg doses of milvexian administered under fed condition on Day 1 in healthy participants (Part 2). To assess the PK of rFVIIa in healthy participants (Part 2).	—

Measure

Time frame

To assess the safety and tolerability of 4F-PCC and rFVIIa when co-administered with milvexian to reverse its anticoagulant effects in healthy participants. To assess the pharmacokinetics (PK) of multiple doses of milvexian at 200 mg BID on Days 4 to 7 (Part 1). To assess the pharmacokinetics (PK) of single 100 mg and 500 mg doses of milvexian administered under fed condition on Day 1 in healthy participants (Part 2). To assess the PK of rFVIIa in healthy participants (Part 2).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)