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New combo pill matches separate heart drugs in healthy volunteers

NCT ID NCT07201545

Knowledge-focused Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checked if a single pill containing three cholesterol-lowering drugs works the same as taking them separately. It involved 58 healthy adults aged 18 to 60. The goal was to see if the combination pill is absorbed similarly, not to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

58 people

The number who actually took part.

Started

Oct 2025

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

A participant is eligible for the study if he/she fulfills all of the following inclusion criteria: 1. Healthy male and female participants ≥18 and ≤60 years, at the time of signing the informed consent. 2. Body mass index (BMI) ≥18.5 and ≤30.0 kg/m\^2. 3. Female participants of childbearing potential agree to undergo pregnancy tests, and if with a non-vasectomized nor infertile male partner, agree to use an appropriate method of contraception. 4. No clinically relevant diseases captured in medical history. 5. No clinically relevant abnormalities on physical examination. 6. No clinically relevant abnormalities on vital signs. 7. No clinically relevant abnormalities on 12-lead electrocardiogram (ECG). 8. No clinically relevant abnormalities on clinical laboratory tests. 9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above the upper limit of normal range (ULN). 10. Estimated renal creatinine clearance (CrCl) above the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m\^2. 11. Willingness to accept and comply with all study procedures and restrictions. 12. Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening). 13. Ability to comprehend and willingness to freely sign the informed consent. A participant is not eligible for the study at Screening if he/she fulfills any of the exclusion criteria as specified in the protocol.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy subjects

Contacts and locations

Locations

  • BlueClinical Phase I BlueClinical - Investigação e Desenvolvimento em Saúde, Lda.

    Porto, 4250-449, Portugal

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