A Phase I Dose Escalation and Food Effect Study of Isotretinoin

JRCT ID: jRCT2071220075

Registered date:25/11/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Severe acne vulgaris
• Date of first enrollment: 28/11/2022
• Target sample size: 36
• Study type: Interventional

Intervention(s)

[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

Outcome(s)

Primary Outcome

[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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 44age old
• Gender: Male

Include criteria

-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)

Exclude criteria

-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.

Related Information

• Primary Sponsor: Toida Tsuneyuki