MK-7602 Multiple Ascending Dose Study in Healthy Participants

2023-503738-36-00 Protocol MK-7602-002 Human pharmacology (Phase I) - Other Ended

Start 12 May 2023 · End 10 Nov 2023 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol MK-7602-002

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 40
Countries 1
Sites 1

Malaria

1. To evaluate the safety and tolerability of multiple doses of MK-7602 over a period of 7 days. 2. To obtain preliminary plasma pharmacokinetic data following multiple dose regimens of MK-7602 over a period of 7 days.

Key facts

Sponsor
Merck Sharp & Dohme LLC
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Parasitic Diseases [C03]
Trial duration
12 May 2023 → 10 Nov 2023
Decision date (initial)
2023-05-02
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Merck Sharp & Dohme LLC

External identifiers

EU CT number
2023-503738-36-00
WHO UTN
U1111-1287-8998

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Pharmacogenetic, Others

1. To evaluate the safety and tolerability of multiple doses of MK-7602 over a period of 7 days.
2. To obtain preliminary plasma pharmacokinetic data following multiple dose regimens of MK-7602 over a period of 7 days.

Conditions and MedDRA coding

Malaria

VersionLevelCodeTermSystem organ class
20.0 PT 10025487 Malaria 100000004862

Regulatory references

EU CT numberTitleSponsor
2022-001845-19 A Single Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-7602 in Healthy Adult Participants and the Effects of Itraconazole on the Pharmacokinetics of MK-7602

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. In good health

Exclusion criteria 4

  1. History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  2. History of cancer (malignancy)
  3. Has a positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
  4. Had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 11

  1. Number of Participants Who Experience At least One Adverse Event (AE)
  2. Number of Participants who Discontinue Study Treatment Due to an AE
  3. Area Under the Curve Time 0 to End of the Dosing Interval (AUC0-tau) of MK-7602
  4. Maximum Plasma Concentration (Cmax) of MK-7602
  5. Through Plasma Concentration (Ctrough) of MK-7602
  6. Time of Maximum Plasma Concentration (Tmax) of MK-7602
  7. Apparent Plasma Terminal Half-life (t1/2) of MK-7602
  8. Apparent Total Clearance of MK-7602 from Plasma After Oral Administration (CL/F)
  9. Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-7602
  10. Accumulation Ratio for AUC0-tau of MK-7602
  11. Accumulation Ratio for Cmax of MK-7602

Investigational products

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

Test 2

MK-7602

PRD9855540 · Product

Active substance
MK-7602
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
400 mg milligram(s)
Max total dose
2600 mg milligram(s)
Max treatment duration
7 Week(s)
Authorisation status
Not Authorised
MA holder
MERCK & CO. INC.
Paediatric formulation
No
Orphan designation
No

MK-7602

PRD9855541 · Product

Active substance
MK-7602
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
400 mg milligram(s)
Max total dose
2600 mg milligram(s)
Max treatment duration
7 Week(s)
Authorisation status
Not Authorised
MA holder
MERCK & CO. INC.
Paediatric formulation
No
Orphan designation
No

Placebo 2

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

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
Russ Carstens

Public contact point

Organisation
Merck Sharp & Dohme LLC
Contact name
Russ Carstens

Third parties 6

OrganisationCity, countryDuties
Universitair Ziekenhuis Gent
ORG-100021542
 Gent, Belgium Laboratory analysis
Pharma Medica Research Inc.
ORG-100011951
 Mississauga, Canada Laboratory analysis
Perceptive Eclinical Limited
ORG-100041144
 Nottingham, United Kingdom Other
Azenta US Inc.
ORG-100016263
 Indianapolis, United States Other
Infinity Biologix LLC
ORG-100040369
 Piscataway, United States Laboratory analysis
Parexel International Corp.
ORG-100007310
 Auburndale, United States Other

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ended 40 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 2023-05-12 2023-11-09 2023-05-16 2023-09-26

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_2023-503738-36
SUM-56298
 2024-11-08T08:40:53 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Results Plain Language Summary 2024-11-08T08:41:05 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_2023-503738-36_BEL_DE_for pub 25SEP2024
Laypersons summary of results (for publication) Results Plain Language Summary_2023-503738-36_BEL_FR_for pub 25SEP2024
Laypersons summary of results (for publication) Results Plain Language Summary_2023-503738-36_BEL_NL_for pub 25SEP2024
Laypersons summary of results (for publication) Results Plain Language Summary_2023-503738-36_EN_for pub 25SEP2024
Summary of results (for publication) Final Analysis_2023-503738-36_for pub 07NOV2024

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-03-24 Belgium Acceptable
2023-05-02
 2023-05-02

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