Breast FeedingPhase 1LIN-PK-01NCT02220348
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
A Phase 1 study testing linaclotide in people with Breast Feeding and Constipation, run by Forest Laboratories at 2 sites in United States.
Trial summary
The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Feeding, Constipation, Irritable Bowel Syndrome
- What is being tested?
- linaclotide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2014to 31 May 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Be a lactating female who has been actively breastfeeding or pumping for at least 4 weeks
- Be already taking linaclotide therapeutically for Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)
- Weaning must not be underway
- Be willing to breastfeed or pump regularly during the study to maintain milk supply and discontinue breastfeeding for the 24-hour period of breast milk collection
Who cannot join
- Clinically significant disease state in any body system, except for the indication being treated with linaclotide
- Any structural abnormality of the gastrointestinal (GI) tract, or a disease or condition that can affect GI motility
- Participation in any other clinical investigation using an experimental drug within 90 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa
Iowa City, Iowa, 52242
Digestive Disease Specialists Inc (DDSI)
Oklahoma City, Oklahoma, 73112
About this study
Official title: An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically
The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically.
- Conditions
- Breast Feeding, Constipation, Irritable Bowel Syndrome
- Being tested
- linaclotide
- Keywords
- Linzess
- Medical subject headings
- Breast Feeding, Constipation, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linaclotideDrug
Also called Linzess
| Study group | Role | What they receive |
|---|---|---|
| linaclotide | Experimental | Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration Receives: Drug: linaclotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
Measured: From Baseline (Day 1) to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study start31 Jul 2014
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramesh Boinpally, PhD, Study director, Forest Research Institute, an affiliate of Allergan plc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220348
- Sponsor's protocol ID
- LIN-PK-01
- Acronym
- LIN-PK-01
- Status last verified
- Dec 2020
- First submitted
- 12 Aug 2014
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically
- ClinicalTrials.gov ID
- NCT02220348
- Acronym / sponsor ID
- LIN-PK-01 / LIN-PK-01
- Conditions
- Breast Feeding, Constipation, Irritable Bowel Syndrome
- Keywords
- Linzess
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2014 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 19 Aug 2014 (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 purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| linaclotide | Experimental | Drug: linaclotideLinaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be a lactating female who has been actively breastfeeding or pumping for at least 4 weeks
- Be already taking linaclotide therapeutically for Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)
- Weaning must not be underway
- Be willing to breastfeed or pump regularly during the study to maintain milk supply and discontinue breastfeeding for the 24-hour period of breast milk collection
Key exclusion criteria (3 listed)
- Clinically significant disease state in any body system, except for the indication being treated with linaclotide
- Any structural abnormality of the gastrointestinal (GI) tract, or a disease or condition that can affect GI motility
- Participation in any other clinical investigation using an experimental drug within 90 days
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 |
|---|---|---|
| linaclotideAlso: Linzess | Drug | linaclotide |
Primary outcome
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
Time frame: From Baseline (Day 1) to Day 4
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 19 Dec 2020.
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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.
Ramesh Boinpally, PhD study director
Forest Research Institute, an affiliate of Allergan plc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing linaclotide in people with Breast Feeding and Constipation, run by Forest Laboratories at 2 sites 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 3 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk (time frame: From Baseline (Day 1) to Day 4). 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 19 Dec 2020.