HealthyPhase 1NCT02833831
Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Participants
A Phase 1 study testing ALS-008176 and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effect of supratherapeutic exposures of ALS-008176 on the QT/ corrected QT interval (QTc) interval in healthy participants (Panel 2). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ALS-008176 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2016to 24 Feb 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in protocol
- A female participant must be of non-childbearing potential, defined as either: a) Postmenopausal- A postmenopausal state is defined as no menses for at least 12 months without an alternative medical cause and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (> 40 International units per liter [IU/L] or International units/milliliter [mIU/mL]); b) Permanently sterile- Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy
- During the study and for a minimum of one spermatogenesis cycle (defined as approximately 90 days) after receiving the (last dose of) study drug, a male participant: a) who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/film/cream/suppository); b) who is sexually active with a pregnant woman must use a condom; c) must agree not to donate sperm
- Female partners of male participants must either be surgically sterilized, postmenopausal (amenorrhea for a minimum of 1 year) or, if of childbearing potential, must agree to use at least one of the following contraceptive methods for 90 days following the last dose of study drug: a nonhormonal intrauterine device with spermicide; contraceptive sponge with spermicide, diaphragm with spermicide, cervical cap with spermicide, or oral, implantable, transdermal, or injectable hormonal contraceptives
- A female participant must have a negative serum beta human chorionic gonadotropin (b-hCG) pregnancy test at screening and on Day -1
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- A female participant must agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the (last dose of) study drug
- Participants must have a body mass index (BMI); weight (kilogram [kg])/height^2 (meter [m]^2) between 18.0 and 30.0 kg/m^2 (inclusive) at screening
- Participants must have a blood pressure (supine after at least 5 minutes rest) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
- Participants must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: a) Sinus rhythm (heart rate between 45 and 100 beats per minute (bpm), inclusive); b) QT interval corrected for heart rate according to Fridericia (QTcF) interval between 350 milliseconds (ms) and 430 ms for male participants, and between 350 ms and 450 ms for female participants (inclusive); c) QRS interval of <110 ms; d) PR interval <=200 ms; e) Morphology consistent with healthy cardiac conduction and function
- Participants must be non-smokers for at least 3 months prior to screening
- Participants must be healthy on the basis of a medical evaluation that reveals the absence of any clinically significant abnormality and includes a complete physical examination, medical and surgical history, vital signs, ECGs, and the results of blood biochemistry and hematology tests and a urinalysis performed at screening. If there are abnormalities the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
- Participants must have normal values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (<= 1.0*upper limit of laboratory normal range [ULN])
Who cannot join
- Participants has a history of 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, 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
- Participants with one or more laboratory abnormalities at screening as defined in the Protocol
- Participants with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardias, heart blocks and incomplete and complete right and left bundle branch blocks
- Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
- Participants with a past history of heart arrhythmias (extra systolic beats or tachycardia at rest) or with a history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia or family history of short/long QT syndrome, or sudden unexplained death at a young age [less than or equal to 40 years], drowning or sudden infant death in a first degree relative [that is, sibling, offspring, or biological parent])
- Participants with electrolyte abnormalities (hypokalemia, hypocalcemia, hypomagnesemia) of grade 2 or above within 21 days prior to the (first) intake of the study drug
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- Participants with any skin condition likely to interfere with ECG electrode placement or adhesion
- Participants with a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues
- Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
- Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
- Participants with presence of any febrile illness or symptoms of upper or lower respiratory tract infection in the 14 days before the (first) administration of study drugs
- Participant has taken any disallowed therapies as noted in Concomitant Therapy before the planned (first) intake of study drug
- Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (including barbiturates, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamine, tetrahydrocannabinol, phencyclidine, and tricyclic antidepressants) at screening
- Participant has known allergies, hypersensitivity, or intolerance to ALS-008176, moxifloxacin or its excipients
- Participant has known allergy to heparin or history of heparin-induced thrombocytopenia
- Participant has donated blood or blood products or had substantial loss of blood (more than 500 milliliter) within 3 months before the (first) administration of study drug or intention to donate blood or blood products during the study
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the planned (first) intake of study drug
- Participant is a woman who is pregnant or breastfeeding
- Participant is a man who plans to father a child while enrolled in this study or within 90 days after the (last) intake of study drug, or who is unwilling to use acceptable methods of contraception as outlined in Protocol
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive, or other clinically active liver disease, or tests positive for HBsAg or anti HCV at screening
- Participant has a history of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection, or tests positive for HIV-1 or -2 at screening
- The participant has preplanned surgery or procedures that would interfere with the conduct of the study
- Vulnerable participant (example, incarcerated individuals)
- Participant with lack of good/reasonable venous access
- Participant is an employee of the Investigator or study site with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, or a family member of the employees or the Investigator, or an employee of the Sponsor
- Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has previously been dosed with ALS-008176 in more than 3 single-dose studies with ALS-008176
- Participant has previously been dosed with ALS-008176 in a multiple-dose study with ALS 008176
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Double-dummy, Randomized, 3-Period Cross-over, Placebo- and Positive Controlled Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Subjects
The primary objective of this study is to evaluate the effect of supratherapeutic exposures of ALS-008176 on the QT/ corrected QT interval (QTc) interval in healthy participants (Panel 2).
Read the detailed description
This is a two-part Phase 1 study consisting of a dose escalation part (Part 1) and a TQT part (Part 2), performed in two separate panels (Panels 1 and 2). Panel 1 will be a double blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study medication assigned to participants by chance), placebo controlled dose escalation study in healthy participants to determine the safety, tolerability and pharmacokinetics of ALS-008176 after administration of single doses of 1500 milligrams (mg), 2500 mg and 3000 mg under fasted conditions. The final dose to be used in the Panel 2 will be determined based on the results of this dose escalation part. An interim analysis will be conducted on Panel 1 to select the dose for Panel 2. Panel 2 will be a double blind, double dummy, randomized, 3 period crossover (the same medications provided to all participants but in different sequence), placebo and positive controlled study to evaluate the effect of ALS-008176 on the QT/QTc interval in healthy participants. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- ALS-008176, Placebo, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALS-008176Drug
Participants will receive a single dose of ALS-008176 orally.
PlaceboDrug
Matching Placebo will be administered.
MoxifloxacinDrug
Participants will receive a single dose of moxifloxacin 400 mg.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Group 1 | Experimental | Participants will receive Treatment A (a single dose of ALS-008176 1,500 mg) or Treatment B (a single dose of placebo) under fasted conditions. Receives: Drug: ALS-008176; Drug: Placebo |
| Part 1: Group 2 | Experimental | Participants will receive Treatment C (a single dose of ALS-008176 2,500 mg) or Treatment D (a single dose of placebo) under fasted conditions. Receives: Drug: ALS-008176; Drug: Placebo |
| Part 1: Group 3 | Experimental | Participants will receive Treatment E (a single dose of ALS-008176 3,000 mg) or Treatment F (a single dose of placebo) under fasted conditions. Receives: Drug: ALS-008176; Drug: Placebo |
| Part 2: Sequence GHI | Experimental | Participants will receive Treatment G (a single dose of ALS-008176 3,000 mg + a single dose of moxifloxacin placebo under fasted conditions) then Treatment H (a single dose of ALS-008176 placebo + a single dose of moxifloxacin 400 mg under fasted conditions) then Treatment I (a single dose of ALS-008176 placebo + a single dose of moxifloxacin placebo under fasted conditions). There will be a washout period of at least 14 days between subsequent treatments. Receives: Drug: ALS-008176; Drug: Placebo; Drug: Moxifloxacin |
| Part 2: Sequence HIG | Experimental | Participants will receive Treatment H then Treatment I and then Treatment G. There will be a washout period of at least 14 days between subsequent treatments. Receives: Drug: ALS-008176; Drug: Placebo; Drug: Moxifloxacin |
| Part 2: Sequence IGH | Experimental | Participants will receive Treatment I then Treatment G and then Treatment H. There will be a washout period of at least 14 days between subsequent treatments. Receives: Drug: ALS-008176; Drug: Placebo; Drug: Moxifloxacin |
| Part 2: Sequence IHG | Experimental | Participants will receive Treatment I then Treatment H and then Treatment G. There will be a washout period of at least 14 days between subsequent treatments. Receives: Drug: ALS-008176; Drug: Placebo; Drug: Moxifloxacin |
| Part 2: Sequence HGI | Experimental | Participants will receive Treatment H then Treatment G and then Treatment I. There will be a washout period of at least 14 days between subsequent treatments. Receives: Drug: ALS-008176; Drug: Placebo; Drug: Moxifloxacin |
| Part 2: Sequence GIH | Experimental | Participants will receive Treatment G then Treatment I and then Treatment H. There will be a washout period of at least 14 days between subsequent treatments. Receives: Drug: ALS-008176; Drug: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Corrected QT intervals (QTc)
Change from baseline in QTc intervals with Fredericia correction will be analyzed.
Measured: Baseline up to Day 2
Secondary outcomes (15)
Number of participants with adverse events as a measure of safety and tolerability
Measured: 10 to 14 days after last study drug intake
Change from baseline in ECG parameters: RR interval, PR interval and QRS interval
Change from baseline in other ECG parameters (RR interval, PR interval and QRS interval) will be analyzed.
Measured: Baseline up to Day 2
ALS-008112 and ALS 008144 plasma concentration-effect relationship for changes in QT/QTc (Panels 1 and 2)
Measured: up to Day 15 in Panel 1; up to Day 2 in Panel 2
Change from Baseline in QT/QTc interval in healthy subjects (Panel 2)
Measured: up to Day 2
Maximum Observed Plasma Concentration (Cmax)
Measured: up to Day 15 in Panel 1; up to Day 2 in Panel 2
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: up to Day 15 in Panel 1; up to Day 2 in Panel 2
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0- last])
Measured: up to Day 15 in Panel 1
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0- infinity])
Measured: up to Day 15 in Panel 1
Elimination Half-Life (t1/2)
Measured: up to Day 15 in Panel 1
Elimination Rate Constant (Lambda[z])
Measured: up to Day 15 in Panel 1
Plasma Concentration at 24 hours post dosing
Measured: up to Day 15 in Panel 1
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24])
Measured: up to Day 15 in Panel 1; up to Day 2 in Panel 2
Change from baseline in Heart Rate
Change from baseline in heart rate will be analyzed.
Measured: Baseline up to Day 2
Change from baseline in T wave morphology
Change from baseline in T wave morphology will be analyzed.
Measured: Baseline up to Day 2
Frequency of T wave morphology changes
T-wave morphology changes will be analyzed.
Measured: up to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start2 Jun 2016
- Primary completion17 Feb 2017
- Study completion24 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833831
- Sponsor's protocol ID
- CR108169
- Other IDs
- 64041575RSV1003
- Status last verified
- Jan 2025
- First submitted
- 21 Jun 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Double-dummy, Randomized, 3-Period Cross-over, Placebo- and Positive Controlled Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02833831
- Acronym / sponsor ID
- CR108169
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 17 Feb 2017 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the effect of supratherapeutic exposures of ALS-008176 on the QT/ corrected QT interval (QTc) interval in healthy participants (Panel 2).
Detailed description
This is a two-part Phase 1 study consisting of a dose escalation part (Part 1) and a TQT part (Part 2), performed in two separate panels (Panels 1 and 2). Panel 1 will be a double blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study medication assigned to participants by chance), placebo controlled dose escalation study in healthy participants to determine the safety, tolerability and pharmacokinetics of ALS-008176 after administration of single doses of 1500 milligrams (mg), 2500 mg and 3000 mg under fasted conditions. The final dose to be used in the Panel 2 will be determined based on the results of this dose escalation part. An interim analysis will be conducted on Panel 1 to select the dose for Panel 2. Panel 2 will be a double blind, double dummy, randomized, 3 period crossover (the same medications provided to all participants but in different sequence), placebo and positive controlled study to evaluate the effect of ALS-008176 on the QT/QTc interval in healthy participants. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part 1: Group 1 | Experimental | Drug: ALS-008176, Drug: PlaceboParticipants will receive Treatment A (a single dose of ALS-008176 1,500 mg) or Treatment B (a single dose of placebo) under fasted conditions. |
| Part 1: Group 2 | Experimental | Drug: ALS-008176, Drug: PlaceboParticipants will receive Treatment C (a single dose of ALS-008176 2,500 mg) or Treatment D (a single dose of placebo) under fasted conditions. |
| Part 1: Group 3 | Experimental | Drug: ALS-008176, Drug: PlaceboParticipants will receive Treatment E (a single dose of ALS-008176 3,000 mg) or Treatment F (a single dose of placebo) under fasted conditions. |
| Part 2: Sequence GHI | Experimental | Drug: ALS-008176, Drug: Placebo, Drug: MoxifloxacinParticipants will receive Treatment G (a single dose of ALS-008176 3,000 mg + a single dose of moxifloxacin placebo under fasted conditions) then Treatment H (a single dose of ALS-008176 placebo + a single dose of moxifloxacin 400 mg under fasted conditions) then Treatment I (a single dose of ALS-008176 placebo + a single dose of moxifloxacin placebo under fasted conditions). There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence HIG | Experimental | Drug: ALS-008176, Drug: Placebo, Drug: MoxifloxacinParticipants will receive Treatment H then Treatment I and then Treatment G. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence IGH | Experimental | Drug: ALS-008176, Drug: Placebo, Drug: MoxifloxacinParticipants will receive Treatment I then Treatment G and then Treatment H. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence IHG | Experimental | Drug: ALS-008176, Drug: Placebo, Drug: MoxifloxacinParticipants will receive Treatment I then Treatment H and then Treatment G. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence HGI | Experimental | Drug: ALS-008176, Drug: Placebo, Drug: MoxifloxacinParticipants will receive Treatment H then Treatment G and then Treatment I. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence GIH | Experimental | Drug: ALS-008176, Drug: Placebo, Drug: MoxifloxacinParticipants will receive Treatment G then Treatment I and then Treatment H. There will be a washout period of at least 14 days between subsequent treatments. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in protocol
- A female participant must be of non-childbearing potential, defined as either: a) Postmenopausal- A postmenopausal state is defined as no menses for at least 12 months without an alternative medical cause and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (> 40 International units per liter [IU/L] or International units/milliliter [mIU/mL]); b) Permanently sterile- Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy
- During the study and for a minimum of one spermatogenesis cycle (defined as approximately 90 days) after receiving the (last dose of) study drug, a male participant: a) who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/film/cream/suppository); b) who is sexually active with a pregnant woman must use a condom; c) must agree not to donate sperm
- Female partners of male participants must either be surgically sterilized, postmenopausal (amenorrhea for a minimum of 1 year) or, if of childbearing potential, must agree to use at least one of the following contraceptive methods for 90 days following the last dose of study drug: a nonhormonal intrauterine device with spermicide; contraceptive sponge with spermicide, diaphragm with spermicide, cervical cap with spermicide, or oral, implantable, transdermal, or injectable hormonal contraceptives
Key exclusion criteria (28 listed)
- Participants has a history of 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, 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
- Participants with one or more laboratory abnormalities at screening as defined in the Protocol
- Participants with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardias, heart blocks and incomplete and complete right and left bundle branch blocks
- Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
- Participants with a past history of heart arrhythmias (extra systolic beats or tachycardia at rest) or with a history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia or family history of short/long QT syndrome, or sudden unexplained death at a young age [less than or equal to 40 years], drowning or sudden infant death in a first degree relative [that is, sibling, offspring, or biological parent])
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 |
|---|---|---|
| ALS-008176Participants will receive a single dose of ALS-008176 orally. | Drug | Part 1: Group 1, Part 1: Group 2, Part 1: Group 3, Part 2: Sequence GHI, Part 2: Sequence GIH, Part 2: Sequence HGI, Part 2: Sequence HIG, Part 2: Sequence IGH, Part 2: Sequence IHG |
| PlaceboMatching Placebo will be administered. | Drug | Part 1: Group 1, Part 1: Group 2, Part 1: Group 3, Part 2: Sequence GHI, Part 2: Sequence GIH, Part 2: Sequence HGI, Part 2: Sequence HIG, Part 2: Sequence IGH, Part 2: Sequence IHG |
| MoxifloxacinParticipants will receive a single dose of moxifloxacin 400 mg. | Drug | Part 2: Sequence GHI, Part 2: Sequence GIH, Part 2: Sequence HGI, Part 2: Sequence HIG, Part 2: Sequence IGH, Part 2: Sequence IHG |
Primary outcome
Change from baseline in Corrected QT intervals (QTc)
Time frame: Baseline up to Day 2
Change from baseline in QTc intervals with Fredericia correction will be analyzed.
15 secondary outcomes
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 10 to 14 days after last study drug intake
Change from baseline in ECG parameters: RR interval, PR interval and QRS interval
Time frame: Baseline up to Day 2
ALS-008112 and ALS 008144 plasma concentration-effect relationship for changes in QT/QTc (Panels 1 and 2)
Time frame: up to Day 15 in Panel 1; up to Day 2 in Panel 2
Change from Baseline in QT/QTc interval in healthy subjects (Panel 2)
Time frame: up to Day 2
Maximum Observed Plasma Concentration (Cmax)
Time frame: up to Day 15 in Panel 1; up to Day 2 in Panel 2
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: up to Day 15 in Panel 1; up to Day 2 in Panel 2
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0- last])
Time frame: up to Day 15 in Panel 1
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0- infinity])
Time frame: up to Day 15 in Panel 1
Elimination Half-Life (t1/2)
Time frame: up to Day 15 in Panel 1
Elimination Rate Constant (Lambda[z])
Time frame: up to Day 15 in Panel 1
Plasma Concentration at 24 hours post dosing
Time frame: up to Day 15 in Panel 1
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24])
Time frame: up to Day 15 in Panel 1; up to Day 2 in Panel 2
Change from baseline in Heart Rate
Time frame: Baseline up to Day 2
Change from baseline in T wave morphology
Time frame: Baseline up to Day 2
Frequency of T wave morphology changes
Time frame: up to Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 ALS-008176 and Moxifloxacin in people with Healthy, 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 13 inclusion and 28 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 3 Feb 2025. 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?
Change from baseline in Corrected QT intervals (QTc) (time frame: Baseline up to Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2025.