MK-8527

Associated long-acting platforms

Oral solid form

Administration route

Oral

Therapeutic area(s)

Use case(s)

Use of drug

Drug information

Delivery device(s)

No delivery device

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

MK-8527-007

Identifier

NCT06045507

Link

https://clinicaltrials.gov/study/NCT06045507

Phase

Phase II

Status

Recruiting

Sponsor

Merck Sharp & Dohme LLC

More details

Not provided

Purpose

Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-11-08

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
2025-02-18

Estimated Completion Date
2025-02-18

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Participants aged 18 to 65 years who are confirmed HIV-uninfected with low-risk of acquiring HIV. Participants are excluded if they have prior use of either islatravir (MK-8591) or MK-8527.

Health status

Study type

Interventional (clinical trial)

Enrollment

350

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Double (Participant, Investigator)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key results

MK-8527-002

Identifier

NCT03615183

Link

https://clinicaltrials.gov/study/NCT03615183

Phase

Phase I

Status

Completed

Sponsor

Merck Sharp & Dohme LLC

More details

Not provided

Purpose

Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-02-11

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2019-09-26

Actual Completion Date
2019-09-26

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Participants are ART-naïve HIV-1 positive individuals with a Body Mass Index (BMI) ≤35 kg/m^2, inclusive.

Health status

Study type

Interventional (clinical trial)

Enrollment

17

Allocation

Randomized

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key results

MK-8527-004

Identifier

NCT05494736

Link

https://clinicaltrials.gov/study/NCT05494736

Phase

Phase I

Status

Completed

Sponsor

Merck Sharp & Dohme LLC

More details

Not provided

Purpose

Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of a Single Dose of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants.

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-11-17

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2024-01-31

Actual Completion Date
2024-01-31

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
No

Comments about the studied populations

Participants are ART-naïve HIV-1 positive individuals aged 18-60 years.

Health status

Study type

Interventional (clinical trial)

Enrollment

20

Allocation

Non-randomized

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key results

MK-8527-008

Identifier

NCT06295796

Link

https://clinicaltrials.gov/study/NCT06295796

Phase

Phase I

Status

Not yet recruiting

Sponsor

Merck Sharp & Dohme LLC

More details

The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.

Purpose

A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)

Interventions

Intervention 1

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-06-24

Anticipated Date of Last Follow-up
2024-04-30

Estimated Primary Completion Date
2024-03-06

Estimated Completion Date
2024-03-06

Actual Primary Completion Date
2024-05-01

Actual Completion Date
2025-04-21

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Moderate and Severe RI * With the exception of RI, is in sufficient health for study participation. * Has stable renal function. Healthy * Matches mean age to participants with moderate and severe RI. * Has normal renal function. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: All participants * History of cancer (malignancy). * Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV). * Had a major surgery or lost significant volume of blood within 56 days prior to dosing. * Donated plasma within 7 days prior to dosing. Moderate and Severe RI * Failed renal transplant or h

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

18

Allocation

Non-randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Not provided

Studied route(s) of administration

Use case

Treatment

Key results

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

Description

4'-SUBSTITUTED NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Brief description

4'-substituted nucleoside derivatives of Formula I and their use in the inhibition of HIV reverse transcriptase, the prophylaxis of infection by HIV, the treatment of infection by HIV, and the prophylaxis, treatment, and delay in the onset or progression of AIDS and/or ARC.

Representative patent

WO2015143712

Category

Compound

Patent holder

Merck Sharp & Dohme Corp.

Exclusivity

Not provided

Expiration date

March 28, 2034

Status

Granted in 36 countries: AL, AM, AP (BW, GH, KE, NA), AT, AU, AZ, BA, BE, BG, BY, CA, CH, CL, CN, CR, CY, CZ, DE, DK, DZ, EA, EE, ES, FI, FR, GB, GC, GE, GI, GR, GY, HN, HR, HU, ID, IE, IL, IR, IS, IT, JO, JP, KR, KZ, LB, LT, LU, LV, MA, ME, MK, MN, MT, MX, MY, NG, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RS, RU, SC, SE, SG, SI, SK, TN, TR, TT, TW, UA, US, VE, VN, ZA Filed in 13 countries: AR, BB, BN, BR, BZ, DO, EC, EG, GT, IN, JM, LK, NI, SV, TH As of 27 June 2024 - MPP Search

Publications

There are no publication

Additional documents

No documents were uploaded

Useful links

There are no additional links

	Collaborate for development Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology Not provided
	Share technical information for match-making assessment Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit Not provided
	Work with MPP to expand access in LMICs In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing Not provided

Not provided