drugset / Trial / NCT02220348
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
NaSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2014-07-31
- Primary completion
- 2019-05-31
- Completion
- 2019-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linaclotide | Peptide | 72 ug | Oral |
| Subject | Linaclotide | Peptide | 145 ug | Oral |
| Subject | Linaclotide | Peptide | 290 ug | Oral |