Study of milk transfer of amenamevir in patients with recurrent herpes simplex during lactation

JRCT ID: jRCTs031230591

Registered date:24/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: herpes simplex
• Date of first enrollment: 24/01/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Lactating patients with a history of recurrent herpes simplex will receive a PIT prescription for AMNV at the practicing institution, and patients will receive a single oral dose of 1200 mg of AMNV postprandial at the onset of recurrent herpes simplex. After taking AMNV medication, milk and blood samples will be collected, milk and plasma samples will be measured, and adverse event assessments will be performed.

Outcome(s)

• Primary Outcome: RID calculated using milk drug concentration Cave[AUC (0, 24h)] when AMNV is taken

Secondary Outcome

1) RID calculated using the Cmax concentration of the drug in milk when AMNV is taken
2) RID calculated using the milk drug concentration Cave[AUC (0, 48h)] when taking AMNV
3) Plasma drug concentration of AMNV
4) Frequency and rate of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 37age old
• Gender: Female

Include criteria

1) Patients with a previous diagnosis of recurrent herpes simplex
2) Patients with at least 1 recurrence of herpes simplex in the past 1 year
3) Patients who are breast-feeding within 1 year after delivery at the time of consent
4) Patients who are between 18 and 37 years of age at the time of consent
5) Patients weighing between 40 kg and 70 kg at the time of consent
6) Patients who are judged by the principal investigator or a research associate to be able to abstain from breastfeeding for 48 hours after taking AMNV
7) Patients who freely and voluntarily consent to participate in this study in writing.

Exclude criteria

1) Patients who have ingested drugs, foods, or beverages listed in the Contraindications or Precautions section of the AMNV package insert within 14 days prior to obtaining consent
2) Patients requiring dietary restrictions due to comorbidities, etc.
3) Patients on extreme diet restrictions due to dieting, etc.
4) Patients with a history of hypersensitivity to AMNV
5) Patients with diabetes mellitus, hepatitis B or C, tuberculosis, mastitis, comorbidity or history of malignancy
6) Patients with a history of HIV infection or comorbidity or history of AIDS
7) Patients who are pregnant or may become pregnant, or who wish to become pregnant during the study period
8) Other patients deemed ineligible by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Murashima Atsuko
• Source(s) of Monetary Support: Maruho Co., Ltd.