Healthy VolunteersPhase 1NCT03856970
Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers
A Phase 1 study testing Microgestin®, Levothyroxine and Glyburide in people with Healthy Volunteers, run by Ironwood Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary objectives of this study are the following: To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single oral dose alone and in combination with IW-3718 in healthy adult female participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Microgestin®, Levothyroxine and Glyburide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2019to 3 Jul 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is healthy, ambulatory, and 18-50 years of age (inclusive) at screening visit.
- Weighs at least 50 kg and has a body mass index within 18-35 kg/m2 at the screening visit.
- Is not pregnant or breastfeeding at the time of the screening visit and has negative serum pregnancy tests at the screening visit and check-in.
- Other inclusion criteria per protocol.
Who cannot join
- Has used any prescription drugs, herbal supplements, over-the-counter medication, or dietary supplements (vitamins included) within 4 weeks prior to dosing. If needed, (ie, incidental and limited need), acetaminophen is acceptable.
- Has consumed grapefruit or grapefruit juice within 4 weeks prior to dosing or plans to consume grapefruit or grapefruit juice before 7 days following the last dose.
- Has a significant illness that has not resolved within 2 weeks prior to dosing.
- Has a history of immunodeficiency diseases, including a positive human immunodeficiency virus test result.
- Has a positive hepatitis B surface antigen or hepatitis C antibody test result.
- Is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.
- Other exclusion criteria per protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Parallel, Sequential, Multi-part Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of an Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers
The primary objectives of this study are the following:
- To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single oral dose alone and in combination with IW-3718 in healthy adult female participants.
- To evaluate the PK of levothyroxine following a single oral dose alone and in combination with IW-3718 in healthy adult participants.
- To evaluate the PK of glyburide following a single oral dose alone and in combination with IW-3718 in healthy adult participants.
- To evaluate the PK of digoxin following a single oral dose alone and in combination with IW-3718 in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Microgestin®, Levothyroxine, Glyburide, Digoxin, IW-3718
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microgestin®Drug
Also called ethinyl estradiol 30 μg and norethindrone 1500 μg
30 μg/1500 μg tablets for oral administration
LevothyroxineDrug
600 μg tablets for oral administration
GlyburideDrug
5 mg tablets for oral administration
DigoxinDrug
0.25 mg tablets for oral administration
IW-3718Drug
500-mg film-coated tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Healthy Volunteers | Experimental | Microgestin® (EE 30 μg and NET 1500 μg) single dose (Day 1). After a 10-14 day washout, Microgestin® single dose (Day 14) PLUS IW-3718 1500 mg twice daily (Days 13 to 19). Receives: Drug: Microgestin®; Drug: IW-3718 |
| Part 2: Healthy Volunteers | Experimental | Levothyroxine 600 μg single dose (Day 1). After a 35-39 day washout, levothyroxine 600 μg single dose (Day 39) PLUS IW-3718 1500 mg twice daily (Days 38 to 41). Receives: Drug: Levothyroxine; Drug: IW-3718 |
| Part 3: Healthy Volunteers | Experimental | Phase 1: Glyburide 5 mg single dose (Day 1). After a 7-10 day washout, glyburide 5 mg single dose (Day 11) PLUS IW-3718 1500 mg twice daily (ie, Days 10 to 14).
Phase 2: Digoxin 0.25 mg single dose (Day 23). After a 10-14 day washout, digoxin 0.25 mg mg single dose (Day 35) PLUS IW-3718 1500 mg twice daily (Days 34 to 42). Receives: Drug: Glyburide; Drug: Digoxin; Drug: IW-3718 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK of EE and NET: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t)
Measured: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose
PK of EE and NET: AUC From Time 0 Extrapolated to Infinity (AUC0-inf)
Measured: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose
PK of EE and NET: Maximum Observed Plasma Concentration (Cmax)
Measured: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose
PK of EE and NET: Time to Maximum Observed Plasma Concentration (Tmax)
Measured: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose
PK of EE and NET: Terminal Phase Half-Life (t1/2)
Measured: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose
PK of Levothyroxine: AUC0-t
Measured: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose
PK of Levothyroxine: AUC0-inf
Measured: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose
PK of Levothyroxine: Cmax
Measured: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose
PK of Levothyroxine: Tmax
Measured: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose
PK of Levothyroxine: t1/2
Measured: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose
PK of Glyburide: AUC0-t
Measured: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose
PK of Glyburide: AUC0-inf
Measured: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose
PK of Glyburide: Cmax
Measured: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose
PK of Glyburide: Tmax
Measured: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose
PK of Glyburide: t1/2
Measured: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose
PK of Digoxin: AUC0-t
Measured: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose
PK of Digoxin: AUC0-inf
Measured: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose
PK of Digoxin: Cmax
Measured: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose
PK of Digoxin: Tmax
Measured: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose
PK of Digoxin: t1/2
Measured: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose
Secondary outcomes (5)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations due to TEAEs
Measured: Part 1: up to Day 27 (±1 day); Part 2: up to Day 49 (±1 day); Part 3: Day 50 (±1 day)
Number of Participants With ≥1 Clinically Significant Changes in Clinical Laboratory Test Results
Measured: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42
Number of Participants With ≥1 Clinically Significant Changes in Vital Sign Measurements
Measured: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42
Number of Participants With ≥1 Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Results
Measured: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42
Number of Participants With ≥1 Clinically Significant Changes in Physical Examination Findings
Measured: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start11 Mar 2019
- Primary completion25 Jun 2019
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zurab Machaidze, MD, Study director, Ironwood Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856970
- Sponsor's protocol ID
- C3718-103
- Status last verified
- Jul 2019
- First submitted
- 26 Feb 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Parallel, Sequential, Multi-part Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of an Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03856970
- Acronym / sponsor ID
- C3718-103
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 27 Feb 2019 (actual)
- 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 objectives of this study are the following:
- To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single oral dose alone and in combination with IW-3718 in healthy adult female participants.
- To evaluate the PK of levothyroxine following a single oral dose alone and in combination with IW-3718 in healthy adult participants.
- To evaluate the PK of glyburide following a single oral dose alone and in combination with IW-3718 in healthy adult participants.
- To evaluate the PK of digoxin following a single oral dose alone and in combination with IW-3718 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Healthy Volunteers | Experimental | Drug: Microgestin®, Drug: IW-3718Microgestin® (EE 30 μg and NET 1500 μg) single dose (Day 1). After a 10-14 day washout, Microgestin® single dose (Day 14) PLUS IW-3718 1500 mg twice daily (Days 13 to 19). |
| Part 2: Healthy Volunteers | Experimental | Drug: Levothyroxine, Drug: IW-3718Levothyroxine 600 μg single dose (Day 1). After a 35-39 day washout, levothyroxine 600 μg single dose (Day 39) PLUS IW-3718 1500 mg twice daily (Days 38 to 41). |
| Part 3: Healthy Volunteers | Experimental | Drug: Glyburide, Drug: Digoxin, Drug: IW-3718Phase 1: Glyburide 5 mg single dose (Day 1). After a 7-10 day washout, glyburide 5 mg single dose (Day 11) PLUS IW-3718 1500 mg twice daily (ie, Days 10 to 14). Phase 2: Digoxin 0.25 mg single dose (Day 23). After a 10-14 day washout, digoxin 0.25 mg mg single dose (Day 35) PLUS IW-3718 1500 mg twice daily (Days 34 to 42). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is healthy, ambulatory, and 18-50 years of age (inclusive) at screening visit.
- Weighs at least 50 kg and has a body mass index within 18-35 kg/m2 at the screening visit.
- Is not pregnant or breastfeeding at the time of the screening visit and has negative serum pregnancy tests at the screening visit and check-in.
- Other inclusion criteria per protocol.
Key exclusion criteria (7 listed)
- Has used any prescription drugs, herbal supplements, over-the-counter medication, or dietary supplements (vitamins included) within 4 weeks prior to dosing. If needed, (ie, incidental and limited need), acetaminophen is acceptable.
- Has consumed grapefruit or grapefruit juice within 4 weeks prior to dosing or plans to consume grapefruit or grapefruit juice before 7 days following the last dose.
- Has a significant illness that has not resolved within 2 weeks prior to dosing.
- Has a history of immunodeficiency diseases, including a positive human immunodeficiency virus test result.
- Has a positive hepatitis B surface antigen or hepatitis C antibody test result.
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 |
|---|---|---|
| Microgestin®Also: ethinyl estradiol 30 μg and norethindrone 1500 μg30 μg/1500 μg tablets for oral administration | Drug | Part 1: Healthy Volunteers |
| Levothyroxine600 μg tablets for oral administration | Drug | Part 2: Healthy Volunteers |
| Glyburide5 mg tablets for oral administration | Drug | Part 3: Healthy Volunteers |
| Digoxin0.25 mg tablets for oral administration | Drug | Part 3: Healthy Volunteers |
| IW-3718500-mg film-coated tablets for oral administration | Drug | Part 1: Healthy Volunteers, Part 2: Healthy Volunteers, Part 3: Healthy Volunteers |
Primary outcome
PK of EE and NET: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t)
Time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose
PK of EE and NET: AUC From Time 0 Extrapolated to Infinity (AUC0-inf)
Time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose
PK of EE and NET: Maximum Observed Plasma Concentration (Cmax)
Time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose
PK of EE and NET: Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose
PK of EE and NET: Terminal Phase Half-Life (t1/2)
Time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose
PK of Levothyroxine: AUC0-t
Time frame: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose
PK of Levothyroxine: AUC0-inf
Time frame: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose
PK of Levothyroxine: Cmax
Time frame: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose
PK of Levothyroxine: Tmax
Time frame: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose
PK of Levothyroxine: t1/2
Time frame: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose
PK of Glyburide: AUC0-t
Time frame: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose
PK of Glyburide: AUC0-inf
Time frame: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose
PK of Glyburide: Cmax
Time frame: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose
PK of Glyburide: Tmax
Time frame: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose
PK of Glyburide: t1/2
Time frame: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose
PK of Digoxin: AUC0-t
Time frame: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose
PK of Digoxin: AUC0-inf
Time frame: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose
PK of Digoxin: Cmax
Time frame: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose
PK of Digoxin: Tmax
Time frame: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose
PK of Digoxin: t1/2
Time frame: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose
5 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations due to TEAEs
Time frame: Part 1: up to Day 27 (±1 day); Part 2: up to Day 49 (±1 day); Part 3: Day 50 (±1 day)
Number of Participants With ≥1 Clinically Significant Changes in Clinical Laboratory Test Results
Time frame: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42
Number of Participants With ≥1 Clinically Significant Changes in Vital Sign Measurements
Time frame: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42
Number of Participants With ≥1 Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Results
Time frame: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42
Number of Participants With ≥1 Clinically Significant Changes in Physical Examination Findings
Time frame: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42
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 29 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
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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.
Zurab Machaidze, MD study director
Ironwood Pharmaceuticals, Inc.
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 Microgestin®, Levothyroxine and Glyburide in people with Healthy Volunteers, run by Ironwood Pharmaceuticals, Inc. 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 4 inclusion and 7 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 29 Jul 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?
PK of EE and NET: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t) (time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose). The study lists 20 primary outcomes in all. 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 29 Jul 2019.