臨床研究等提出・公開システム

A Phase I Study of Isotretinoin Capsules in Japanese Healthy Adult Male Subjects.
(Dose Escalation and Food Effect Studies)

A Phase I Dose Escalation and Food Effect Study of Isotretinoin

Toida Tsuneyuki

Sun Pharma Japan Ltd.

8-9-5, Nishigotanda, Shinagawa-ku, Tokyo, 141-0031, Japan

JPS.clinicaltrial@sunpharma.com

Yamanaka Tomoe

Sun Pharma Japan Ltd.

8-9-5, Nishigotanda, Shinagawa-ku, Tokyo, 141-0031, Japan

+81-3-5719-6663

JPS.clinicaltrial@sunpharma.com

Complete

Nov. 26, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

basic science

-Japanese healthy male adults aged 18 to 44 years or younger
-Body weight: 55 kg or greater and less than75 kg
-Body mass index (BMI): 18.5 kg/m2 or greater and less than 25 kg/m2
-Agreed to implement the contraceptive method described in protocol until 1 month after informed consent is obtained and administration of the investigational product (for part 2, administration in period 2)

-History of allergy or hypersensitivity to isotretinoin, other retinoids or vitamin A, or a history of drug hypersensitivity or intolerance determined by the investigator to be potentially compromising subject or study safety.
-Significant history (person or family) or current medical history of chronic infection, organ damage or organ dysfunction, particularly cardiovascular disorder (hypertension, etc.), asthma, diabetes mellitus, bone loss (osteoporosis) or bone fragility, anorexia nervosa, liver disorder, or renal disorder.
-Judged by the investigator to have a history of clinically significant gastrointestinal disease, inflammatory bowel disease, or current disease, or a history of malabsorption within the past year.
-Concurrent, history, or family history of a psychiatric disorder (depression, psychosis, suicidal ideation, etc.).
-Current history of medical conditions requiring regular treatment with prescription drugs.

Male

Severe acne vulgaris

[Part 1 (dose escalation)]
Single oral administration of Isotretinoin capsule (16mg, 32mg, or 64mg) under fasted conditions as below.
Group A : Isotretinoin capsule 16mg 1 capsule or placebo 1 capsule
Group B : Isotretinoin capsule 32mg 1 capsule or placebo 1 capsule
Group C : Isotretinoin capsule 32mg 2 capsules or placebo 2 capsules
[Part 2 (food effect)]
Single oral administration of Isotretinoin capsule 32mg under fasted or fed conditions on period-1 and period-2 as below.
Group D : Isotretinoin capsule 32mg 1 capsule under fed in Period-1 and Isotretinoin capsule 32mg 1 capsule under fasted in Period-2
Group E : Isotretinoin capsule 32mg 1 capsule under fasted in Period-1 and Isotretinoin capsule 32mg 1 capsule under fed in Period-2

[Part 1 (dose escalation)]
Pharmacokinetics:Plasma levels of unchanged isotretinoin and three major metabolites and pharmacokinetic parameters of unchanged isotretinoin and major metabolites
Safety :Adverse events, laboratory values, vital signs, and 12-lead ECG

[Part 2 (food effect)]
Pharmacokinetics:Plasma levels of unchanged isotretinoin and three major metabolites after and after fasting, and pharmacokinetic parameters of unchanged isotretinoin and major metabolites
Safety :Adverse events, laboratory values, vital signs, and 12-lead ECG

+81-92-283-7701

Nov. 25, 2022

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