MK-5684 Food Effect Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

2 Aug 2023 → 31 Jan 2024

Decision date (initial)

2023-07-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-505521-14-00

WHO UTN

U1111-1292-3209

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Others, Pharmacogenetic, Safety

1. To evaluate the effect of a high-fat meal on the plasma pharmacokinetics of MK-5684 as compared to the plasma pharmacokinetics in the fasted state after administration of a single oral 5-mg dose of MK-5684 in healthy male participants.
2. To assess the effect of MK-5684 on steroid hormone levels over time in healthy male participants.

Secondary objectives 2

1. To evaluate safety and tolerability of MK-5684 following single oral 5-mg doses in healthy male participants.
2. To evaluate the effect of a high-fat meal on the plasma pharmacokinetics of MK-5684 as compared to the plasma pharmacokinetics in the fasted state after administration of a single oral 5-mg dose of MK-5684 in healthy male participants.

Conditions and MedDRA coding

refractory metastatic prostate cancer

Regulatory references

Scientific advice from competent authorities

Federal Agency For Medicines And Health Products

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Has a body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2

Exclusion criteria 12

1. Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
2. Has a history of cancer
3. Has a history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
4. Has positive test(s) for hepatitis B surface antigen (HBs Ag), hepatitis C antibodies or human immunodeficiency virus (HIV) serologies
5. Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning at least 2 weeks prior to administration of the initial dose of the study intervention, throughout the study, until the poststudy visit
6. Has received or expected to receive any form of vaccination within 2 weeks of pre-study, throughout the study and poststudy
7. Has any contraindications to prednisone and fludrocortisone
8. Is a smoker and/or used nicotine or nicotine containing products within 3 months of screening
9. Consumes greater than 3 servings of alcoholic beverages as per protocol per day. Participants who consume 4 servings of alcoholic beverages per day may be enrolled at the discretion of the investigator
10. Is a regular user of cannabis, any illicit drugs or has a history of drug abuse within approximately 12 months
11. The investigator has any concern regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study
12. Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

1. Area Under the Concentration-Time Curve From Time Zero to Last Measured Concentration (AUC 0-last)
2. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC 0-inf) of MK-5684
3. Maximum Concentration (Cmax) of MK-5684
4. Percent Change From Baseline in Testosterone Level
5. Percent Change From Baseline in Androstenedione Level
6. Percent Change From Baseline in Pregnenolone Level
7. Percent Change From Baseline in Dehydroepiandrosterone Sulfate (DHEA-S) Level

Secondary endpoints 7

1. Number of Participants Who Experience an Adverse Event (AE)
2. Number of Participants Who Discontinue Study Treatment Due to an AE
3. Time to Maximum Concentration of MK-5684
4. Half-Life (t1/2) of MK-5684
5. Oral Clearance (CL/F) of MK-5684
6. Apparent Volume of Distribution (Vz/F) of MK-5684
7. Terminal Elimination Rate Constant (λz) of MK-5684

Investigational products

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

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Jonathan Belman

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Jonathan Belman

Third parties 7

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 5 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