HealthyPhase 1NCT02770521

A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants

A Phase 1 study testing Treprostinil, LY900014 and Insulin Lispro in people with Healthy, run by Eli Lilly and Company at 1 site in Japan.

Completed

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

Official record

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Trial summary

The aims of this study are to evaluate: The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin) The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy… Read more about this study

Who is it for?: Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Treprostinil, LY900014 and Insulin Lispro
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteJapan
Study dates: May 2016to Jul 2016
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 20 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Overtly healthy Japanese
Body mass index (BMI) 18.5 - 25 kilograms per square meter (kg/m²)
Fasting plasma glucose ≥71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L) (Part B only)
Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study

Who cannot join

Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated in a clinical trial involving an investigational product within the 30 days before study entry.
Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product
Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Trial locations and contacts

1 site in 1 country.

Japan1 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.
Fukuoka, 812-0025

Other trials in Japan

About this study

Official title: A Study to Evaluate the Safety and Tolerability of Subcutaneous Treprostinil and Pharmacokinetics of a Novel LY900014 Formulation in Healthy Japanese Subjects

The aims of this study are to evaluate:

The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin)
The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.

The study has two parts. Participants may only enroll in one part.

Conditions: Healthy
Being tested: Treprostinil, Placebo, LY900014, Insulin Lispro

What participants receive

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

TreprostinilDrug
Administered SC.
PlaceboDrug
Administered SC.
LY900014Drug
Also called Ultra-Rapid Lispro
Administered SC.
Insulin LisproDrug
Administered SC.

Study groups in NCT02770521
Study group	Role	What they receive
Treprostinil (Part A)	Experimental	Treprostinil administered as a single subcutaneous (SC) bolus injection. Receives: Drug: Treprostinil
Placebo (Part A)	Placebo comparator	Placebo administered as a single SC bolus injection. Receives: Drug: Placebo
LY900014 (Part B)	Experimental	LY900014 (test) administered as a single SC bolus injection. Receives: Drug: LY900014
Insulin Lispro (Part B)	Active comparator	Insulin lispro (reference) administered as a single SC bolus injection. Receives: Drug: Insulin Lispro

What is being measured

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

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module.
Measured: Part A: Baseline through Study Completion (up to 14 Days after Last Dose)
Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (Cmax) (Part B)
PK: Insulin Lispro Cmax (Part B)
Measured: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose
PK: Insulin Lispro Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (AUC[0-30min]) (Part B)
PK: Insulin Lispro AUC(0-30min) (Part B)
Measured: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose

Secondary outcomes (2)

PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A)
PK: Treprostinil Tmax (Part A)
Measured: 15, 30, 60 and 120 Minutes Postdose
PK: Maximum Concentration (Cmax) of Treprostinil (Part A)
PK: Cmax of Treprostinil (Part A)
Measured: 15, 30, 60 and 120 Minutes Postdose

Timeline

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

May 2016Jul 2016

First posted12 May 2016 (estimated)
Study startMay 2016
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02770521
Sponsor's protocol ID: 16071
Other IDs: I8B-JE-ITRK
Status last verified: Jul 2016
First submitted: 11 May 2016
Last updated: 4 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Safety and Tolerability of Subcutaneous Treprostinil and Pharmacokinetics of a Novel LY900014 Formulation in Healthy Japanese Subjects
ClinicalTrials.gov ID: NCT02770521
Acronym / sponsor ID: 16071
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: May 2016
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 12 May 2016 (estimated)
Results: Posted 4 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aims of this study are to evaluate:

The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin)
The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.

The study has two parts. Participants may only enroll in one part.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Treprostinil (Part A)	Experimental	Drug: TreprostinilTreprostinil administered as a single subcutaneous (SC) bolus injection.
Placebo (Part A)	Placebo comparator	Drug: PlaceboPlacebo administered as a single SC bolus injection.
LY900014 (Part B)	Experimental	Drug: LY900014LY900014 (test) administered as a single SC bolus injection.
Insulin Lispro (Part B)	Active comparator	Drug: Insulin LisproInsulin lispro (reference) administered as a single SC bolus injection.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Overtly healthy Japanese
Body mass index (BMI) 18.5 - 25 kilograms per square meter (kg/m²)
Fasting plasma glucose ≥71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L) (Part B only)
Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study

Key exclusion criteria (4 listed)

Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated in a clinical trial involving an investigational product within the 30 days before study entry.
Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product
Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TreprostinilAdministered SC.	Drug	Treprostinil (Part A)
PlaceboAdministered SC.	Drug	Placebo (Part A)
LY900014Also: Ultra-Rapid LisproAdministered SC.	Drug	LY900014 (Part B)
Insulin LisproAdministered SC.	Drug	Insulin Lispro (Part B)

Primary outcome

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Part A: Baseline through Study Completion (up to 14 Days after Last Dose)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module.
Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (Cmax) (Part B)
Time frame: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose
PK: Insulin Lispro Cmax (Part B)
PK: Insulin Lispro Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (AUC[0-30min]) (Part B)
Time frame: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose
PK: Insulin Lispro AUC(0-30min) (Part B)

2 secondary outcomes

PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A)
Time frame: 15, 30, 60 and 120 Minutes Postdose
PK: Maximum Concentration (Cmax) of Treprostinil (Part A)
Time frame: 15, 30, 60 and 120 Minutes Postdose

Results and safety

Results posted to the registry on 4 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo/Treprostinil (Part A)	4	4
Treprostinil/Placebo (Part A)	4	4
15 U Insulin Lispro/15 U LY900014/30 U LY900014 (Part B)	2	2
7.5 U LY900014/15 U Insulin Lispro/30 U LY900014 (Part B)	2	2
7.5 U LY900014/15 U LY900014/15 U Insulin Lispro (Part B)	2	2
7.5 U LY900014/15 U LY900014/30 U LY900014 (Part B)	9	9

Primary outcome: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame: Part A: Baseline through Study Completion (up to 14 Days after Last Dose). Number. Unit: participants

Measure	Placebo (Part A) n = 8	Treprostinil (Part A) n = 8	15 U Insulin Lispro (Part B) n = 6	7.5 U LY900014 (Part B) n = 13	15 U LY900014 (Part B) n = 13	30 U LY900014 (Part B) n = 13
Value	0	0	0	0	0	0

Population analysed: All participants who received at least one dose of study drug.

Primary outcome: Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (Cmax) (Part B)

Time frame: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose. Geometric mean (Geometric Coefficient of Variation). Unit: picomoles/liter (pmol/L)

Measure	7.5 U LY900014 (Part B) n = 13	15 U LY900014 (Part B) n = 13	30 U LY900014 (Part B) n = 13
Value	582 (42)	956 (41)	2170 (30)

Population analysed: All participants who received at least one dose of study drug LY900014 in Part B and had evaluable pharmacokinetic data. Per protocol, PK in Part B was not analyzed for 15 U Insulin Lispro (Humalog). This arm was included for only safety analysis.

Primary outcome: PK: Insulin Lispro Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (AUC[0-30min]) (Part B)

Measure	7.5 U LY900014 (Part B) n = 13	15 U LY900014 (Part B) n = 13	30 U LY900014 (Part B) n = 13
Value	174 (57)	273 (51)	585 (31)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through Study Completion (up to 14 Days after Last Dose). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Part A)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Treprostinil (Part A)	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
15 U Insulin Lispro (Part B)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
7.5 U LY900014 (Part B)	0 of 13 (0%)	7 of 13 (53.8%)	0 of 13
15 U LY900014 (Part B)	0 of 13 (0%)	7 of 13 (53.8%)	0 of 13
30 U LY900014 (Part B)	0 of 13 (0%)	2 of 13 (15.4%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treprostinil, LY900014 and Insulin Lispro in people with Healthy, run by Eli Lilly and Company at 1 site in Japan.

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 4 inclusion and 4 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 4 Jun 2020. 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 Japan. 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. Some participants in this study may receive a placebo. 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 4 Jun 2020). 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?

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Part A: Baseline through Study Completion (up to 14 Days after Last Dose)). The study lists 3 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 NCT02770521.

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 4 Jun 2020.