A Phase 1 Study to Assess the Excretion Balance, Pharmacokinetics, and Metabolism of [14C] Dc 806 in Healthy Male Participants.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dice Therapeutics Inc.

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

24 Aug 2023 → 2 Oct 2023

Decision date (initial)

2023-08-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacokinetic, Safety

To investigate the rate and routes of excretion, including the mass balance, after single oral dose administration of 800 mg DC-806 containing 3.7 MBq (100 µCi) of [14C] DC 806 in urine and feces
To assess the PK of TRA and DC-806 in whole blood and plasma after single oral dose administration of 800 mg DC 806 containing 3.7 MBq (100 µCi) of [14C] DC 806 in healthy male participants

Secondary objectives 2

1. To assess the safety and tolerability after single oral dose administration of DC-806 in healthy male participants.
2. To profile and identify the metabolites of DC-806 in whole blood, plasma, urine, and feces, if feasible.

Conditions and MedDRA coding

Healthy

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. Sex : male.
2. Age : 18 years to 55 years, inclusive, at screening.
3. Body mass index : 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening.
4. Weight : ≥50 kg at screening.
5. Status : healthy participants.
6. 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.
7. All prescribed medication must have been stopped at least 14 days prior to admission to the clinical site on Day -1.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Willing and able to sign the ICF.

Exclusion criteria 16

1. Employee of ICON or the Sponsor.
2. History of relevant drug and/or food allergies, in the opinion of the Investigator.
3. Irregular defecation pattern (less than once per 2 days on average), in the opinion of the Investigator.
4. Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily.
5. 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.
6. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year prior to screening.
7. 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.
8. 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).
9. Positive screen for hepatitis B surface antigen, HCV antibodies, or HIV 1 and 2 antibodies.
10. 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.
11. 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.
12. Significant and/or acute illness within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
13. 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.
14. 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.
15. Unsuitable veins for infusion or blood sampling as determined by the Investigator or study staff.
16. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Excretion and recovery of TRA and DC-806 (and any major metabolites, if applicable): in urine: CLr, Aeurine, and fe%urine
2. Excretion and recovery of TRA and DC-806 (and any major metabolites, if applicable): in feces (and vomitus, if available): Aefeces, Aetotal, fe%feces, and fe%total (and Aevomit and fevomit, if applicable) for TRA
3. PK parameters of TRA and DC-806 (and any major metabolites, if applicable) in whole blood and plasma, as appropriate: Cmax, tmax, kel, t1/2, AUC0-t, and AUC0-inf
4. PK parameters of TRA and DC-806 (and any major metabolites, if applicable) in whole blood and plasma, as appropriate: CL/F and Vz/F (DC-806 only)
5. PK parameters of TRA and DC-806 (and any major metabolites, if applicable) in whole blood and plasma, as appropriate: Whole blood to plasma ratios for Cmax and AUC0-inf (TRA only)

Secondary endpoints 5

1. Adverse events
2. Clinical laboratory
3. Vital signs
4. 12-lead electrocardiogram
5. Quantified and identified DC-806 major metabolites

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dice Therapeutics Inc.

Sponsor organisation

Dice Therapeutics Inc.

Address

400 East Jamie Court Suite 300

City

South San Francisco

Postcode

94080-6230

Country

United States

Scientific contact point

Organisation

Dice Therapeutics Inc.

Contact name

Muhammad Baluom

Public contact point

Organisation

Dice Therapeutics Inc.

Contact name

Paula Opal

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications