A clinical study of MK-1403 in healthy men

2023-504695-23-00 Protocol MK-1403-001 Human pharmacology (Phase I) - First administration to humans Ended

Start 15 Jun 2023 · End 7 Oct 2023 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol MK-1403-001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Ended
Participants planned 24
Countries 1
Sites 1

Atherosclerosis

1. To evaluate the safety and tolerability of single oral doses of MK-1403 administered with an additive.

Key facts

Sponsor
Merck Sharp & Dohme LLC
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
15 Jun 2023 → 7 Oct 2023
Decision date (initial)
2023-06-14
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Merck Sharp & Dohme LLC

External identifiers

EU CT number
2023-504695-23-00
WHO UTN
U1111-1289-9668

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenetic, Pharmacokinetic, Safety, Pharmacodynamic, Others

1. To evaluate the safety and tolerability of single oral doses of MK-1403 administered with an additive.

Secondary objectives 4

  1. To characterize the plasma pharmacokinetics of MK-1403 following administration of single oral doses of MK-1403 with the additive in the fasted state.
  2. To evaluate the effects of a high-fat meal on the plasma pharmacokinetics of MK-1403 as compared to the plasma pharmacokinetics in the fasted state after administration of a single oral dose of MK-1403 with the additive.
  3. To estimate and compare the plasma pharmacokinetics of MK-1403 administration with the additive in separate capsule formulations versus a combination capsule formulation (ie, F2 formulation of MK-1403 [with the additive] versus F1 formulation of MK-1403 [without the additive] coadministered with placebo P2 [with the additive]).
  4. To evaluate the effect of additive dose on MK-1403 plasma pharmacokinetics.

Conditions and MedDRA coding

Atherosclerosis

VersionLevelCodeTermSystem organ class
20.0 LLT 10003601 Atherosclerosis 10047065

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Assigned male sex at birth, from 18 years to 45 years of age inclusive
  2. Agrees to use contraception unless confirmed to be azoospermic or remain abstinent during the intervention period and 7 days afterwards for MK-1403

Exclusion criteria 4

  1. Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  2. Has a history of cancer (malignancy)
  3. Has had a major surgery within 4 weeks prior to the prestudy visit
  4. Received a live vaccination within 1 month prior to the prestudy visit

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Number of Participants Who Experience At least One Adverse Event (AE)
  2. Number of Participants Who Discontinue Study Treatment Due to an AE

Secondary endpoints 7

  1. Area Under the Curve from Time 0 to Infinity (AUC0-inf) of MK-1403
  2. Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-1403
  3. Maximum Plasma Concentration (Cmax) of MK-1403
  4. Plasma Concentration at 24 hours (C24) of MK-1403
  5. Time to Maximum Plasma Concentration (Tmax) of MK-1403
  6. Apparent Plasma Terminal Half-life (t1/2) of MK-1403
  7. Area Under the Curve from Time 0 to Time of the Last Quantifiable Concentration (AUC0-t) of MK-1403

Investigational products

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

Test 3

MK-1403 F1

PRD10343870 · Product

Active substance
MK-1403
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
500 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Not Authorised
MA holder
MERCK & CO. INC.
Paediatric formulation
No
Orphan designation
No

MK-1403 F1

PRD10343869 · Product

Active substance
MK-1403
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
500 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Not Authorised
MA holder
MERCK & CO. INC.
Paediatric formulation
No
Orphan designation
No

MK-1403 F2

PRD10343871 · Product

Active substance
MK-1403
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
500 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Not Authorised
MA holder
MERCK & CO. INC.
Paediatric formulation
No
Orphan designation
No

Placebo 2

Microcrystalline cellulose, Sodium Caprate

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Microcrystalline cellulose, Lactose monohydrate, Magnesium Stearate (non-bovine)

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

290 Total trials 92 Recruiting 184 Ended
Commercial
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
Julie Fiore

Public contact point

Organisation
Merck Sharp & Dohme LLC
Contact name
Julie Fiore

Third parties 9

OrganisationCity, countryDuties
Merck & Co. Inc.
ORG-100002006
 Kenilworth, United States Laboratory analysis
Q Squared Solutions Holdings LLC
ORG-100043288
 Valencia, United States Laboratory analysis
Iqvia Limited
ORG-100008655
 Livingston, United Kingdom Laboratory analysis
Parexel International Corp.
ORG-100007310
 Auburndale, United States Other
Infinity Biologix LLC
ORG-100040369
 Piscataway, United States Laboratory analysis
Universitair Ziekenhuis Gent
ORG-100021542
 Gent, Belgium Laboratory analysis
Perceptive Eclinical Limited
ORG-100041144
 Nottingham, United Kingdom Other
Merck Sharp & Dohme LLC
ORG-100006323
 West Point, United States Laboratory analysis
Azenta US Inc.
ORG-100016263
 Indianapolis, United States Other

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ended 24 1
Rest of world — 0 —

Investigational sites

Belgium

1 site · Ended
Universitair Ziekenhuis Gent
DRUG, Corneel Heymanslaan 10, 9000, Gent

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2023-06-15 2023-10-06 2023-06-19 2023-09-11

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

TitleSubmission dateStatusType
Final Analysis_2023-504695-23
SUM-49394
 2024-10-02T17:21:12 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Results Plain Language Summary_2023-504695-23_BEL_DE 2024-10-02T17:24:10 Submitted Laypersons Summary of Results
Results Plain Language Summary_2023-504695-23_BEL_FR 2024-10-02T17:23:37 Submitted Laypersons Summary of Results
Results Plain Language Summary_2023-504695-23_BEL_NL 2024-10-02T17:22:28 Submitted Laypersons Summary of Results
Results Plain Language Summary_2023-504695-23_EN 2024-10-02T17:22:00 Submitted Laypersons Summary of Results

Documents 5 files

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

TypeTitleVersion
Laypersons summary of results (for publication) Results Plain Language Summary_2023-504695-23_BEL_DE_for pub 26AUG2024
Laypersons summary of results (for publication) Results Plain Language Summary_2023-504695-23_BEL_FR_for pub 26AUG2024
Laypersons summary of results (for publication) Results Plain Language Summary_2023-504695-23_BEL_NL_for pub 26AUG2024
Laypersons summary of results (for publication) Results Plain Language Summary_2023-504695-23_EN_for pub 26AUG2024
Summary of results (for publication) Final Analysis_2023-504695-23_for pub 08MAY2025

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-05-04 Belgium Acceptable
2023-06-14
 2023-06-14

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