Not yet recruitingPHASE4INTERVENTIONAL

Study to Evaluate the Effect of a Single Oral Dose of Zoliflodacin 3 g on Testicular Function in Healthy Adult Men

This study is investigating a single dose of zoliflodacin and its potential effects on male fertility. We are looking for healthy men, aged 18 to 45, to take part. Participants will be randomly assigned to receive either a 3g dose of zoliflodacin or a placebo (a dummy pill) taken as a liquid. Before starting, we'll collect semen samples to check your fertility. After taking the medicine, we'll follow up with phone calls and a visit at Week 13 to collect more semen and blood samples. If your sperm count significantly drops at Week 13, another follow-up visit will happen at Week 26 to see if it has returned to normal. The aim is to understand if zoliflodacin temporarily affects sperm production.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Global Antibiotics Research and Development Partnership

Enrolment target

200

Start

01 Oct 2026

Estimated completion

01 Nov 2027

Testicular Abnominalies

What is this study about?

This study is designed to carefully look at how a single dose of a medicine called zoliflodacin might affect the testicles in healthy adult men. We want to find out if this medicine, even in just one dose, has any impact on a man's ability to produce sperm. This is important information to gather whenever a new medicine is being developed, to ensure we understand all its potential effects on the body.

To do this, we'll be comparing the effects of zoliflodacin with a 'placebo.' A placebo is an inactive substance, like a dummy pill or a liquid that doesn't contain any medicine. This helps us ensure that any changes we see are truly due to the zoliflodacin and not just something that would have happened anyway or because someone expected a change.

By understanding how zoliflodacin interacts with testicular function, we can build a complete picture of the medicine's profile. This kind of research helps ensure that future medicines are safe and well-understood before they are used more widely. It's a standard and crucial step in medical development.

Key takeaways

This study evaluates how a single dose of zoliflodacin affects male fertility.
Healthy men aged 18-45 can participate.
You will take either zoliflodacin or a dummy pill (placebo).
Participation involves initial screening, a dosing day, phone calls, and clinic visits at Week 13, and potentially Week 26.
Your sperm and hormone levels will be checked regularly.
You will need to use contraception for 3 months after taking the study medicine.

Who may be eligible?

This study is looking for healthy men between the ages of 18 and 45. You should be in generally good health, based on a check-up, your medical history, and blood tests. You'll also need to have healthy sperm counts and other fertility measures when we test them at the start of the study.

Unfortunately, you won't be able to join if you have a history of specific male reproductive health problems, such as certain hormone disorders, issues with your testicles (like a past injury or surgery), or previous fertility problems. We also can't include you if you've had radiation therapy to your testicles or if you have a known allergy to zoliflodacin.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man between 18 and 45 years old?
Are you generally in good health?
Do you have a healthy sperm count and other fertility measures?
Have you never had certain serious male reproductive health problems or surgeries on your testicles?
Are you willing to use effective contraception if you have a female partner who could get pregnant, for 3 months after the study treatment?
Are you able to attend all required appointments for up to 26 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit within 3 weeks before the main study day. This involves a general health check, blood tests, and providing two semen samples (each after not ejaculating for at least 2 days but no more than 7). If you're eligible, you'll be randomly assigned to take either a single dose of zoliflodacin or a placebo as a liquid on Day 1.

Following this, we'll check in with you by phone at Week 1 and Week 7 to ask about your well-being, any side effects, and any other medications you might be taking. You'll then return to the clinic at Week 13 for more tests, including two more semen samples and a blood test to check your hormone levels. If your sperm count has significantly dropped at Week 13, you'll have an additional visit at Week 26 for more semen samples to see if it has returned to normal. The total duration of your participation will be either 13 weeks or 26 weeks, depending on your results.

Potential risks and benefits

Participating in any study comes with potential benefits and risks. While there's no direct personal medical benefit expected from taking part in this specific study, you'll be contributing to important medical research that helps others. There's a potential risk that the study medicine could temporarily affect your sperm count, but we will monitor this closely. You will be fully informed about any known side effects of zoliflodacin. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Parexel EPCU
Verified postcode
Berlin, Germany
Parexel EPCU
Verified postcode
London, United Kingdom

Common questions

What is zoliflodacin?

Zoliflodacin is a medicine being researched, and this study aims to understand its effects on the body, specifically on male fertility.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study medicine but contains no active drug. It helps researchers compare the real effects of the medicine.

Will I know if I'm taking the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study team will know who is getting the active medicine and who is getting the placebo until the end of the study.

Will this study affect my ability to have children?

The study is looking for potential effects on sperm. If your sperm count drops significantly, we'll check again to see if it returns to normal. You'll also be asked to use contraception for 3 months after taking the medicine.

How long does the study last?

Your involvement in the study will last either 13 weeks or, for some participants, up to 26 weeks, depending on the results of your sperm tests.

How to find out more

Jovana Albig, MD

info@gardp.org +41 22 555 19 90 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.