Phase 1 Study on Excretion Balance, Pharmacokinetics, and Metabolism of [14C] DC 806 in Healthy Male Subjects

Trial ID: 2023-505367-36-00
Protocol: DCE806102
Sponsor: Dice Therapeutics Inc.

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Diseases & Conditions

Psoriasis

Objectives

The primary objective of this Phase 1 study is to evaluate the **excretion balance**, **pharmacokinetics**, and **metabolism** of [14C] DC 806 in healthy male participants. Understanding these parameters is crucial for determining the drug's safety profile, absorption, distribution, metabolism, and excretion characteristics, which are essential for further clinical development. No secondary objectives are specified for this study.

Participants

The clinical trial involves a study population consisting of **healthy** male participants. The age range of the participants is categorized under code "3," which typically corresponds to a specific age group, though the exact ages are not specified. The total number of participants is not provided, as the sponsor has not given this information. The trial population was selected to exclude vulnerable populations, ensuring a focus on individuals without significant health concerns. Lifestyle considerations such as diet, physical activity, or habits are not detailed in the available data. The study does not include female participants, and no specific inclusion or exclusion criteria are highlighted in the provided information.

Plans and Procedures

The clinical trial is designed as a **Phase 1** study to evaluate the excretion balance, pharmacokinetics, and metabolism of [14C] DC 806 in healthy male participants. The trial employs a randomized, double-blind, and controlled methodology to ensure the reliability and validity of the results. The estimated duration of the trial spans from August 14, 2023, to September 30, 2023, encompassing both the recruitment and study phases.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve comprehensive health evaluations to confirm the participant's status as healthy. Following successful screening, participants will be enrolled in the study and will attend scheduled follow-up visits. These visits are structured to monitor the pharmacokinetic parameters and metabolic pathways of the investigational compound. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to gather data on the primary and secondary endpoints.

The expected length of participant involvement is approximately six weeks, contingent upon adherence to the study protocol. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is conducted under strict ethical guidelines, ensuring the safety and well-being of all participants throughout the study duration.

Treatment

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes a comprehensive description of the treatments used in this clinical trial.

Efficacy

The clinical trial is in Phase 3, with an estimated recruitment start date of August 14, 2023, and an estimated end date of September 30, 2023. Efficacy will be assessed using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured schedule for measuring, collecting, and analyzing these efficacy parameters, adhering to the standards expected in Phase 3 trials. The methods and tools for efficacy assessment are not specified, but typically include validated scales, laboratory tests, and patient-reported outcomes. The trial's design and execution will ensure that efficacy is evaluated objectively and systematically, in line with clinical trial protocols.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Sex : male.
Age : 18 years to 55 years, inclusive, at screening.
Body mass index : 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening.
Weight : ≥50 kg at screening.
Status : healthy participants.
Participants must agree to use adequate contraception and not donate sperm from admission to the clinical site on Day -1 until 90 days after study drug administration (for details, see Section 3.4.8.2). Adequate contraception for the male participant (and his female partner, if she is of childbearing potential) is defined as using one of the following in combination with a condom: vasectomy, bilateral tubal ligation, hormonal contraceptives, or an intrauterine device. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the participant, is also acceptable. Participants with female partners who are of nonchildbearing potential (for definitions, see Section 3.4.8.2) or who are already pregnant, or male partners, must use a condom from Day -1 until ≥30 days after study drug administration.
All prescribed medication must have been stopped at least 14 days prior to admission to the clinical site on Day -1.
All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John’s wort) must have been stopped at least 7 days (or 5 half-lives for certain medications, whichever is longer) prior to admission to the clinical site on Day -1. Occasional use of acetaminophen/paracetamol (eg, up to 2 grams per day) is permitted during this period and throughout the study.
Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening and admission to the clinical site (including the 24-hour stay, as applicable), and during confinement at the clinical site.
Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, and energy drinks), and grapefruit (juice) from 48 hours (2 days) prior to admission to the clinical site on Day -1, and during confinement at the clinical site.
Willingness to abstain from any strenuous physical exercise from 96 hours (4 days) prior to admission on Day -1 and during confinement at the clinical site.
Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, 12-lead ECG, and vital signs, as judged by the Investigator.
Willing and able to sign the ICF.

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Exclusion Criteria

Employee of ICON or the Sponsor.
History of relevant drug and/or food allergies, in the opinion of the Investigator.
Irregular defecation pattern (less than once per 2 days on average), in the opinion of the Investigator.
Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily.
Unwilling or unable to abstain from tobacco products within the 48 hours (2 days) prior to screening, admission on Day -1, and during confinement in the clinical site.
History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year prior to screening.
Positive drug and/or alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or admission to the clinical site on Day -1.
Average intake of more than 24 units of alcohol per week (clinical site standard: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
Positive screen for hepatitis B surface antigen, HCV antibodies, or HIV 1 and 2 antibodies.
Participation in a drug study within 30 days prior to study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to study drug administration in the current study.
Donation or loss of more than 450 mL of blood within 60 days prior to study drug administration. Donation or loss of more than 1.5 liters of blood in the 10 months prior to study drug administration in the current study.
Significant and/or acute illness within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
For a study with a radiation burden of >0.1 mSv, the participant will be excluded if he participated in another study with a radiation burden of >0.1 mSv and ≤1 mSv in the period of 1 year prior to screening; a radiation burden of >1.1 mSv and ≤2 mSv in the period of 2 years prior to screening; a radiation burden of >2.1 mSv and ≤3 mSv in the period of 3 years prior to screening, etc.
Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a clinical study in the period of 1 year prior to screening.
Unsuitable veins for infusion or blood sampling as determined by the Investigator or study staff.
Any other condition or prior therapy that, in the Investigator’s opinion, would confound or interfere with the evaluation of safety, tolerability, or PK of the study drug, interfere with study compliance, or preclude informed consent.