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ObesityPhase 1NCT03586843

A Study of JNJ-64565111 After Single Subcutaneous Administration at Different Injection Sites in Otherwise Healthy Overweight/Obese Adult Participants and a Study of JNJ-6456511 in Otherwise Healthy Obese Adult Participants After Multiple Dose

A Phase 1 study testing JNJ-64565111 in people with Obesity, run by Janssen Research & Development, LLC 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
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Trial summary

The purpose of this study is to compare the relative bioavailability of JNJ-64565111 between subcutaneous (SC) administrations in the upper arm versus the abdomen, and between SC administrations in the thigh versus the abdomen in otherwise healthy overweight/obese participants (Part A) and to assess the… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
JNJ-64565111
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
29 Jun 2018to 17 Mar 2019
Phase
Phase 1
Are there results?
None posted in the registry

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Part A and Part B:
  • If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry, throughout the study and for at least 30 days after the last dose of study drug
  • Part A:
  • If a woman, must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative serum pregnancy test on Day -1 of each treatment period
  • Body mass index (weight [kilogram {kg}]/height^2 [meter {m}^2]) between 25-40 kg/m^2 (inclusive), and body weight not less than 75 kg
  • Part B:
  • A woman must have a negative serum beta-hCG pregnancy test at screening, on Day 1, and before each SC injection, except on Day 8(+1). On Day 8(+1), women must have a negative serum or urine pregnancy test depending on the test performed at the investigator's discretion
  • Body mass index (weight [kg]/height^2 [m]^2) between 30-50 kg/m^2 (inclusive), and body weight not less than 75 kg

Who cannot join

  • Part A and Part B:
  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities (that is [ie], fasting triglycerides greater than or equal to (>=)500 milligram per deciliter (mg/dL) and/or total cholesterol >=300 mg/dL), significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or at admission to the study center as deemed appropriate by the investigator
  • Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator. Participants with serum sodium less than (<)130 milliequivalents per liter (mEq/L) at screening should be excluded
  • Known allergy to the study drug or any of the excipients of the formulation
  • Donated blood or blood products or had substantial loss of blood (more than 500 milliliters [mL]) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study or within 2 months after the completion of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Single-dose, Open-label, Randomized, 3-period, 6-sequence, Crossover Study to Evaluate the Relative Bioavailability of JNJ-64565111 After Single Subcutaneous Administration at Different Injection Sites in Otherwise Healthy Overweight/Obese Adult Subjects and A Multiple Dose, Open-label, Titration Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ 64565111 in Otherwise Healthy Obese Adult Subjects

The purpose of this study is to compare the relative bioavailability of JNJ-64565111 between subcutaneous (SC) administrations in the upper arm versus the abdomen, and between SC administrations in the thigh versus the abdomen in otherwise healthy overweight/obese participants (Part A) and to assess the gastrointestinal tolerability of JNJ-64565111 following a dose titration in otherwise healthy obese participants at 6 weeks (Part B).

Conditions
Obesity
Being tested
JNJ-64565111
Medical subject headings
Obesity

What participants receive

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

  • JNJ-64565111Drug

    JNJ-64565111 SC will be administered on Day 1 of Treatment Periods 1, 2 and 3 as per the assigned treatment sequence in Part A and as ascending doses on Days 1, 8, 15, 22, 29 and 36 in Part B.

Study groups in NCT03586843
Study groupRoleWhat they receive
Part A: Treatment Sequence ABC: JNJ-64565111ExperimentalParticipants will receive Treatment A (JNJ-64565111 subcutaneous [SC] administration in the upper arm in fasted condition) on Day 1 of Treatment Period 1; followed by Treatment B (JNJ-64565111 SC administration in the thigh in fasted condition) on Day 1 of Treatment Period 2 and then Treatment C (JNJ-64565111 SC administration in the abdomen in fasted condition) on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last pharmacokinetic (PK) sample collection and dosing on Day 1 of subsequent treatment period.
Receives: Drug: JNJ-64565111
Part A: Treatment Sequence ACB: JNJ-64565111ExperimentalParticipants will receive Treatment A on Day 1 of Treatment Period 1; followed by Treatment C on Day 1 of Treatment Period 2 and then Treatment B on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period.
Receives: Drug: JNJ-64565111
Part A: Treatment Sequence BAC: JNJ-64565111ExperimentalParticipants will receive Treatment B on Day 1 of Treatment Period 1; followed by Treatment A on Day 1 of Treatment Period 2 and then Treatment C on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period.
Receives: Drug: JNJ-64565111
Part A: Treatment Sequence BCA: JNJ-64565111ExperimentalParticipants will receive Treatment B on Day 1 of Treatment Period 1; followed by Treatment C on Day 1 of Treatment Period 2 and then Treatment A on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period.
Receives: Drug: JNJ-64565111
Part A: Treatment Sequence CAB: JNJ-64565111ExperimentalParticipants will receive Treatment C on Day 1 of Treatment Period 1; followed by Treatment A on Day 1 of Treatment Period 2 and then Treatment B on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period.
Receives: Drug: JNJ-64565111
Part A: Treatment Sequence CBA: JNJ-64565111ExperimentalParticipants will receive Treatment C on Day 1 of Treatment Period 1; followed by Treatment B on Day 1 of Treatment Period 2 and then Treatment A on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period.
Receives: Drug: JNJ-64565111
Part B: JNJ-64565111ExperimentalParticipants will receive a single SC ascending doses of JNJ-64565111 on Days 1, 8, 15, 22, 29 and 36.
Receives: Drug: JNJ-64565111

What is being measured

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

  1. Part A: Maximum Observed Serum Concentration of JNJ-64565111 (Cmax)

    Cmax is the maximum observed serum analyte concentration.

    Measured: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 192, 384, 672 and 984 hours postdose; at End of study (EOS): 7-14 days after Day 42 of Treatment Period 3 (approximately up to 26 weeks)

  2. Part A: Area Under the Serum Concentration Time Curve From Time 0 to Infinite Time (AUC [0-infinity])

    AUC [0-infinity) is the area under the serum concentration versus time curve from time 0 to infinite time, calculated as AUClast + Clast/lambda(z) where Clast is the last observed measurable (non- below quantification limit [BQL]) concentration.

    Measured: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 192, 384, 672 and 984 hours postdose; at EOS: 7-14 days after Day 42 of Treatment Period 3 (approximately up to 26 weeks)

  3. Part A: Area Under the Serum Concentration Time Curve From Time 0 to Time of the Last Measurable Concentration (AUC [0-last])

    AUC (0-last) is the area under the serum concentration versus time curve from time 0 to time of the last measurable (non-below quantification limit [BQL]) concentration, calculated by linear linear trapezoidal summation.

    Measured: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 192, 384, 672 and 984 hours postdose; at EOS: 7-14 days after Day 42 of Treatment Period 3 (approximately up to 26 weeks)

  4. Part B: Number of Participants with Gastrointestinal Adverse Events as a Measure of Safety and Tolerability of JNJ-64565111

    Number of participants with gastrointestinal adverse events will be assessed. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.

    Measured: Approximately up to 6 weeks

Secondary outcomes (5)

  1. Part A and Part B: Number of Participants with Antibodies to JNJ-64565111

    Number of participants with antibodies to JNJ-64565111 will be reported.

    Measured: Part A: Predose, 144, 672 and 984 hours postdose; at EOS: 7-14 days after Day 42 of Treatment Period 3 (approximately up to 26 weeks); Part B: predose (Day 1), postdose on Day 39 or End of Study/Early Withdrawal (approximately up to 7 weeks)

  2. Part A and Part B: Number of Participants with Adverse Events

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.

    Measured: Part A: approximately up to 26 weeks, Part B: approximately up to 11 weeks

  3. Part B: Number of Gastrointestinal Adverse Events Over Time Upon Multiple Dosing

    The number of gastrointestinal adverse events over time will be evaluated upon multiple dosing of JNJ-64565111.

    Measured: Approximately up to 6 weeks

  4. Part B: Maximum Observed Serum Concentration of JNJ-64565111 (Cmax)

    Cmax (maximum observed serum analyte concentration) after last dose of JNJ-64565111.

    Measured: From Day 36 until Day 43

  5. Part B: Area Under the Serum Concentration Versus Time Curve Over the Dosing Interval (AUCtau)

    AUCtau (measure of the serum drug exposure over the dosing interval) after the last dose of JNJ-64565111.

    Measured: From Day 36 until Day 43

Timeline

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

  1. First posted16 Jul 2018
  2. Study start29 Jun 2018
  3. Primary completion17 Mar 2019
  4. Study completion17 Mar 2019

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03586843
Sponsor's protocol ID
CR108509
Other IDs
64565111OBE1001
Status last verified
Apr 2019
First submitted
29 Jun 2018
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64565111 in people with Obesity, run by Janssen Research & Development, LLC 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 6 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 16 Apr 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Part A: Maximum Observed Serum Concentration of JNJ-64565111 (Cmax) (time frame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 192, 384, 672 and 984 hours postdose; at End of study (EOS): 7-14 days after Day 42 of Treatment Period 3 (approximately up to 26 weeks)). The study lists 4 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 NCT03586843.

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 16 Apr 2019.

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