AzTrials
AzTrials

Erectile DysfunctionPhase 1NCT01401543

A Bioavailability Study of LY2452473 and Tadalafil

A Phase 1 study testing LY2452473, Tadalafil and LY900010 in people with Erectile Dysfunction, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study compares LY2452473 taken orally as a 5 milligram (mg) capsule at the same time as a 5 mg tadalafil tablet with three different combination tablets (LY900010) of 5 mg LY2452473 and 5 mg tadalafil taken orally. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Erectile Dysfunction
What is being tested?
LY2452473, Tadalafil and LY900010
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Jul 2011to Sep 2011
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Overtly healthy male, as determined by medical history and physical examination
  • Are between a body mass index of 18.5 and 30 kilograms per meter squared (kg/m²), inclusive at screening
  • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
  • Normal blood pressure and heart rate (HR; sitting) as determined by the investigator
  • Have venous access sufficient to allow blood sampling
  • Are reliable and willing to make themselves available for the duration of the study, and will abide by the research unit policies and procedures and study restrictions
  • Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
  • Men must agree to use a reliable method of birth control (for example, vasectomy, condom with contraceptive foam, abstinence, or female partner's use of oral contraceptives or Norplant®; a reliable barrier method of birth control [diaphragm with contraceptive jelly]; or intrauterine device), during the study and for 1 month following the last dose of study drug

Who cannot join

  • Have known allergies to LY2452473, tadalafil, or related compounds
  • History of severe allergies or multiple adverse drug reactions
  • Have a history or presence of cardiovascular, respiratory, hepatic (including history of cholecystectomy), renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Any abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the investigator places the subject at an unacceptable risk for study participation
  • Show evidence of significant active neuropsychiatric disease
  • History of significant retinal pathology
Show all 23Show fewer
  • Have a history of glaucoma
  • Have a history of unexplained syncope episodes
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Show evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies
  • Intended use of over-the-counter or herbal remedies within 7 days prior to dosing or during the study
  • Intended use of prescription medication within 14 days prior to dosing or during the study
  • Are not willing to refrain from consumption of any food, or drink any beverage containing grapefruit, pomelo, or starfruit for at least 2 weeks prior to the start of the study until its conclusion
  • Heavy caffeine drinkers defined by a regular intake of more than 5 cups of coffee (or equivalent in xanthine-containing beverages) per day or subjects who have not had consistent daily caffeine consumption for 1 month prior to study entry or subjects not willing to maintain consistent caffeine consumption during the study
  • Use of drugs of abuse, as evidenced by history, and/or positive findings on urinary drug screening
  • Have an average weekly alcohol intake that exceeds 14 units per week or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 ounces [oz] or 360 milliliters (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • Is currently a smoker or uses tobacco products on a regular basis and has not had consistent daily tobacco use for 1 month prior to study entry or subjects not willing to maintain consistent tobacco use during the study
  • Have a history of blood donation of 1 unit (approximately 450 mL) or more in the last 3 months prior to study entry
  • Have previously completed or withdrawn from this study or any other study investigating LY2452473
  • Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
  • Deemed unsuitable by the investigator for any other reason
  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: LY2452473 Formulation Exploratory Bioavailability Study

This study compares LY2452473 taken orally as a 5 milligram (mg) capsule at the same time as a 5 mg tadalafil tablet with three different combination tablets (LY900010) of 5 mg LY2452473 and 5 mg tadalafil taken orally. The study will evaluate the amount of LY2452473 and tadalafil circulating in the blood for each treatment. Side effects will be documented. This study is approximately 34 days not including screening.

Being tested
LY2452473, Tadalafil, LY900010
Keywords
testosterone, energy, libido, erectile function, weak muscles
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY2452473Drug

    Administered orally

  • TadalafilDrug

    Also called LY450190, Cialis

    Administered orally

  • LY900010Drug

    Administered orally

Study groups in NCT01401543
Study groupRoleWhat they receive
5 mg LY2452473 + 5 mg TadalafilActive comparator5-mg LY2452473 oral capsule and 5-mg tadalafil oral tablet, administered orally, once only. There will be a washout period of at least 7 days between doses of study drug.
Receives: Drug: LY2452473; Drug: Tadalafil
LY900010 (particle size #1)ExperimentalSingle combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a smaller particle size (d90 = 10 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value.
Receives: Drug: LY900010
LY900010 (particle size #2)ExperimentalSingle combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with an intermediate particle size (d90 = 25 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value.
Receives: Drug: LY900010
LY900010 (particle size #3)ExperimentalSingle combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a larger particle size (d90 = 40 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value.
Receives: Drug: LY900010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2452473

    Measured: Predose up to 96 hours postdose for each of the 4 treatment periods

  2. Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2452473

    Measured: Predose up to 96 hours postdose for each of the 4 treatment periods

Secondary outcomes (2)

  1. Pharmacokinetics: AUC(0-∞) of Tadalafil

    Measured: Predose up to 96 hours postdose for each of the 4 treatment periods

  2. Pharmacokinetics: Cmax of Tadalafil

    Measured: Predose up to 96 hours postdose for each of the 4 treatment periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionSep 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01401543
Sponsor's protocol ID
13326
Other IDs
I4K-MC-GPEA
Status last verified
Mar 2019
First submitted
21 Jul 2011
Last updated
14 Jun 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2452473, Tadalafil and LY900010 in people with Erectile Dysfunction, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2452473 (time frame: Predose up to 96 hours postdose for each of the 4 treatment periods). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01401543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in